protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03355664 | 6.5 | Study drug regimens | | OverviewTRACII | drugregimens |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
... | [] |
NCT03355664 | 6.5.1 | Artemether-lumefantrine | Currently available as dispersible or standard tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.
*Target dose/range:*
The dose of artemether-lumefantrine is administered... | [
"Target dose/range:"
] |
NCT03355664 | 6.5.2 | Amodiaquine | Amodiaquine is available in tablets of 150, 300 and 600 mg. The weight-based treatment schedule in appendix 2 aims for a dosage of approximately 10mg (4.5-15mg)/kg/day amodiaquine for three days, thereby approaching the WHO target dose and range of 10 mg (7.5-15mg)/kg/day. | [] |
NCT03355664 | 6.5.3 | Primaquine | Primaquine is available in tablets of 7.5 and 15 base mg. The weight-based treatment schedule in appendix 2 aims for a dosage of approximately 0.15-0.375 mg/kg on day one thereby approaching the 0.25 mg base/kg single dose recommended by the WHO. | [] |
NCT03355664 | 6.6 | Procedures during hospitalisation | A physical examination, measurement of vital signs will be performed daily and every six hours on indication. A symptom questionnaire will be taken daily to help identify adverse events. Follow up procedures
After patients are discharged, they will be followed up at Day 5 and 7 for:
- Day 5 and 7: Malaria blood slide... | [] |
NCT03355664 | 6.6.1 | Time windows | The time-window for the visit on Day 7 is + 1 day and for the visits on Days 14 - 42 is –1 to +2 days. If a patient does not attend, a home-visitor from the study team will try to locate the patient and bring them to the clinic. | [] |
NCT03355664 | 6.6.2 | Additional visits | Patients presenting to the clinic with a fever or other symptoms on unscheduled days will be assessed by the study physician. Their temperature will be recorded and blood smear will be made for any patient with a documented fever (tympanic temperature ≥ 37.5˚C) or a history of fever. Patients will be treated as clinica... | [] |
NCT03355664 | 6.6.3 | Patients with recurrent parasitaemia | Patients with a recurrent falciparum parasitaemia (including mixed with another malaria species) during follow up will have blood taken for the following:
- Repeat parasite count (thick and thin films).
- Dry blood blots (400 microlitres, 4 spots collected on Whatman FTA cards) for:
- o Parasite DNA genotyping for d... | [] |
NCT03355664 | 6.7 | Epidemiological data on place of residence, work, travel history and mobile phone use | In order to have a greater understanding of the possible sites of malaria transmission, and to relate genetic diversity to geographical location, patients or their guardians will be asked a short set of questions on their place of residence, place of work and their history of travel in the last 2 months. In addition, b... | [] |
NCT03355664 | 6.8 | Rescue treatment | The indication for rescue treatment is:
• the development of any danger signs or signs of severe malaria at any point.
Rescue treatment will consist of parenteral artesunate, 2.4 mg/kg IV/IM STAT, followed by 2.4 mg/kg IV/IM at 12 hours and 24 hours and then daily until able to take oral medication.
Parenteral quini... | [] |
NCT03355664 | 6.9 | Analysis | [] | |
NCT03355664 | 6.9.1 | Drug assays | Partner drug concentrations will be measured in plasma samples. These assays will be performed at the Department of Clinical Pharmacology, MORU, Bangkok, Thailand. | [] |
NCT03355664 | 6.9.2 | Analysis of PK data | Pharmacokinetic analyses will be performed by the Department of Clinical Pharmacology, MORU, Bangkok, Thailand at the end of the study period or earlier when requested, for instance by the DSMB. | [] |
NCT03355664 | 6.9.3 | Ex vivo drug sensitivity assay | An *ex vivo* assay will be performed to measure parasite responses to artemisinin derivates and partner drugs according to the latest standards at the time of assessment. Parasites will be also be cryopreserved for future studies. | [] |
NCT03355664 | 6.9.4 | Molecular studies | Parasite DNA will be used for genomic studies including but not limited to microsatellite typing to identify parasite clones and single nucleotide polymorphisms (SNP) typing/whole genome sequencing to generate data for genome-wide association studies of *in vivo*, *ex vivo*, and *in vitro* responses of parasites to art... | [] |
NCT03355664 | 6.9.5 | PCR for quantitative parasitaemia | One of the objectives of this study is to measure assess the parasite clearance dynamics by PCR and compare these with clearance rates estimated using this method to microscopy. | [] |
NCT03355664 | 6.10 | Discontinuation/ Withdrawal of Participants from the Study | Each participant has the right to discontinue the study drug or the study at any time. Data accrued up until the time of discontinuation will be used in the analysis.
In general, the investigator must make every effort to perform the study procedure until day 42, including in the following situations:
- Significant n... | [] |
NCT03355664 | 6.11 | Source Data | Source documents are original documents, data, and records from which participants' CRF data are obtained. These include, but are not limited to, hospital records (from which medical history and previous and concurrent medication may be summarised into the CRF), clinical and office charts, laboratory and pharmacy recor... | [] |
NCT03355664 | 7 | STUDY DRUGS | [] | |
NCT03355664 | 7.1 | Storage of Study Drugs | All efforts will be made to store the study drugs in accordance with the manufacturers' recommendations in a secure area. This may be difficult at some sites where air-conditioned storage rooms are not available. The ACTs and TACTs should be stored between 15°C to 30°C (59°F to 86°F).
Where this is not possible and mo... | [] |
NCT03355664 | 7.2 | Compliance with Study Drugs | Study drugs will be administered as Directly-Observed-Therapy. If the patient vomits, and is redosed; this will be recorded in the CRF. If vomiting within 1 hour occurs again after retreatment, no repeat dosing is allowed. In this case the patient will be treated at the discretion of the Investigator. Each patient shou... | [] |
NCT03355664 | 7.3 | Accountability of the Study Treatment | All movements of study medication will be recorded. Both study medication of individual patient and overall drug accountability records will be kept up to date by the study staff. | [] |
NCT03355664 | 7.4 | Concomitant Medication | Throughout the study, investigators may prescribe concomitant medications or treatments deemed necessary (e.g. antipyretics or anti-emetics) to provide adequate supportive care except for antibiotics with antimalarial activity unless unavoidable (e.g. doxycycline, azithromycin). If these are required the patients will ... | [] |
NCT03355664 | 8 | SAFETY REPORTING | This trial will use drugs that have either been registered or evaluated extensively.
To allow for comparison of safety and tolerability of both new TACTs compared to the ACTs we will record and review all Adverse Events (AEs) and Serious Adverse Events, (SAEs), that occur in the study.
A symptom questionnaire will be... | [] |
NCT03355664 | 8.1 | Definitions | [] | |
NCT03355664 | 8.1.1 | Adverse Event (AE) | An AE is any undesirable event or clinical deterioration that occurs to a study participant during the course of the study; that is, from the time of administration of study drugs until study ends (i.e., until the follow up visit) whether or not that event is considered related to the study drugs, or to a concomitant d... | [] |
NCT03355664 | 8.1.2 | Serious Adverse Event | A serious adverse event is an AE that:
- results in death
- is life-threatening i.e. the patient was at risk of death at the time of the AE
- requires inpatient hospitalisation or prolongation of existing hospitalisation
- results in persistent or significant disability/incapacity
- is a congenital anomaly/birth defec... | [] |
NCT03355664 | 8.1.3 | QTc Interval | Electrocardiograms (ECGs) will be recorded at screening, D0H0, D0H4, D1H24, D1H28, D2H48, D2H52, D2H60 and D2H64, D7 and D28 in order to measure the QTc-interval.
The screening ECG can be used as the baseline (D0H0) ECG, if the time for administration of the D0H0 study drug is within 30 minutes of the time of the scre... | [] |
NCT03355664 | 8.1.4 | Biochemical assessments | In order to assess the safety of the novel TACTs basic biochemical assessments of markers related to hepatic and renal toxicity will be performed on day 0 (baseline) day 3, day 7 and 28. If found to be abnormal the values will be graded according to the Division of AIDS table mentioned in section 8.3.1 and followed up ... | [] |
NCT03355664 | 8.2 | Reporting Procedures for Serious Adverse Events | All SAEs must be reported by the site investigator to the Sponsor, within one day of his or her awareness of the SAE. The CRF documenting the SAE, should be faxed or emailed to the CTSG, (Fax No +66 (0) 2 354 9169; email TACTCV@tropmedres.ac).
Further reports should be submitted, if required, until the SAE is resolved... | [] |
NCT03355664 | 8.3 | Evaluating Adverse Events and Serious Adverse Events | [] | |
NCT03355664 | 8.3.1 | Assessment of Intensity | Each adverse event will be graded according to the Division of AIDS table for grading the severity of ADULT AND PEDIATRIC adverse Events Version 2.0, November 2014 which will be included in the safety monitoring SOP.
If an adverse event is not listed in the Division of AIDS table, the Investigator will assess the seve... | [] |
NCT03355664 | 8.3.2 | Clarification of the difference in meaning between 'severe' and 'serious' | The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache). This is not the same as "serious", which is based on the outcome or crit... | [] |
NCT03355664 | 8.3.3 | Assessment of relatedness | The investigator is obligated to assess the relationship between study drug and the occurrence of each AE/SAE using the following categories of relatedness:
- Definite: clear-cut temporal association
- Probable: clear-cut temporal association, with improvement upon drug withdrawal, and not reasonably explained by the ... | [] |
NCT03355664 | 8.3.4 | Outcome | The investigator will follow-up the AE and SAE until resolution or until no further medically relevant information can be expected. AE and SAE outcome will be classified as follows:
- Continuing/ongoing
- Resolved
- Resolved with sequelae
- Permanent
- Fatal | [] |
NCT03355664 | 9 | STATISTICAL CONSIDERATIONS | [] | |
NCT03355664 | 9.1 | Sample size justification | The sample size calculation is based on the primary endpoint of the 42-day PCR corrected ACPR. Our hypothesis is that artemether-lumefantrine+amodiaquine is superior to artemether-lumefantrine. Earlier efficacy studies of artemether-lumefantrine found an efficacy of 82.4 and 86.5% [\[13,](#page-40-10) [14\]](#page-40-1... | [] |
NCT03355664 | 9.2 | Statistical Analyses | Analysis of other endpoints will be described in a Statistical Analysis Plan. A brief overview is given below. | [] |
NCT03355664 | 9.2.1 | Proportions | These will be compared using chi squared or Fisher's exact test, as appropriate. Crude proportions will be calculated with the exact 95% confidence intervals (CI), where relevant. | [] |
NCT03355664 | 9.2.2 | Continuous data | These will be summarised by medians (IQR, ranges) and means (standard deviations, 95% CIs), as appropriate, and will include the parasite counts and laboratory parameters. Comparisons of continuous data will be assessed using the paired/unpaired t tests or the sign rank/Mann Whitney U tests, as appropriate.
Analyses o... | [] |
NCT03355664 | 9.2.3 | Pharmacokinetic data | The pharmacokinetic parameters of lumefantrine and amodiaquine during the first 24 hours will be estimated with a non-compartment analysis and will include standard PK parameters such as Cmax, Tmax and AUC. Nonlinear mixed-effects modelling will be employed to integrate all available data for an in-depth analysis of th... | [] |
NCT03355664 | 9.2.4 | Safety analysis | Safety analyses will be based on the whole population that get administered the study drug. Safety and tolerability of TACTs versus ACTs will be assessed by comparing the frequency (%) of adverse events and serious adverse events, with particular attention to abdominal pain, appetite perturbation, biochemical markers o... | [] |
NCT03355664 | 9.2.5 | Adverse events | Adverse events will be graded according to Division of AIDS table for grading the severity of ADULT AND PEDIATRIC adverse Events Version 2.0, November 2014 which will be included in the safety monitoring SOP.
All adverse event summaries will refer to treatment emergent adverse events, i.e. adverse events that newly st... | [] |
NCT03355664 | 9.2.6 | Assessment of relationship between PK parameters and ECG findings. | In addition to the results of the safety analysis an exploratory analysis of the ECG data will be conducted. The ECG parameters will be compared with the PK properties of the drugs using appropriate statistical methods. | [] |
NCT03355664 | 9.2.7 | Interim analyses | Interim analysis reports on the safety of TACTs will be provided by the Project Coordinator in collaboration with the Trial Statistician (Dr Mavuto Mukaka, e-mail: Mavuto@tropmedres.ac) after the first 60 and 180 patients. To assess the safety of the novel TACTs the DSMB will review the interim analysis reports. | [] |
NCT03355664 | 10 | DIRECT ACCESS TO SOURCE DATA/DOCUMENTS | Direct access will be granted to authorised representatives from the sponsor and host institution and the regulatory authorities, if applicable, to permit trial-related monitoring and inspections. | [] |
NCT03355664 | 11 | QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES | The study will be conducted in accordance with the current approved protocol, ICH GCP, any national regulations that may apply to this study and standard operating procedures. The WWARN will be engaged in assuring QA/QC of study execution in collaboration with the MORU Clinical Trials Support Group (CTSG). Their role w... | [] |
NCT03355664 | 11.1 | Monitoring | Study sites may have in place a system for internal monitoring. In addition, regular external monitoring of all sites will be performed by the MORU CTSG according to ICH GCP and a Monitoring Plan. Data will be evaluated for compliance with the protocol and accuracy in relation to source documents. The monitors will che... | [] |
NCT03355664 | 11.2 | DSMB | An independent Data Safety and Monitoring Board (DSMB) will be set up consisting of qualified volunteers with the necessary knowledge of clinical trials. The DSMB will receive summary reports, prior to each meeting. All data reviewed by the DSMB will be in the strictest confidence. A DSMB charter will outline its respo... | [] |
NCT03355664 | 12 | ETHICS | [] | |
NCT03355664 | 12.1 | Declaration of Helsinki | The Investigator will ensure that this study is conducted in compliance with the current revision of the Declaration of Helsinki (Fortaleza 2013). | [] |
NCT03355664 | 12.2 | ICH Guidelines for Good Clinical Practice | The Investigator will ensure that this study is conducted according to any National Regulations and that it will follow the principles of the ICH Guidelines for Good Clinical Practice 1996. | [] |
NCT03355664 | 12.3 | Approvals | The study protocol and its associated documents will be submitted to the Oxford Tropical Research Ethics Committee (OxTREC) and the appropriate local ethics committees for written approval.
The Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the o... | [] |
NCT03355664 | 12.4 | Risks | This study will use drugs that have been studied thoroughly and their toxicities are well described. In general, they are all well tolerated. | [] |
NCT03355664 | 12.4.1 | Risks of artemether-lumefantrine | Reported A/L side effects have generally been mild. The main side effects are GI upset: anorexia (~18%), nausea (~5%), vomiting (~18%), abdominal pain (~5%), and diarrhoea (~10%), headache (~10%), dizziness (~4%), fatigue (~1%) and sleep disturbance (~2%). Other symptoms reported infrequently include palpitations, myal... | [] |
NCT03355664 | 12.4.2 | Risks of amodiaquine | The main side-effects of amodiaquine are nausea, vomiting and fatigue which are mild to moderate in nature. When the drug was used for prophylaxis, rare adverse reactions of agranulocytosis and hepatoxicity were observed. | [] |
NCT03355664 | 12.4.3 | Risks of new partner drug combinations | No interactions between lumefantrine and amodiaquine are expected. Based on the relatively safe and limited side effect profiles of both drugs, no life-threatening interactions between lumefantrine and amodiaquine are expected. In addition, the preliminary results of the TRACII trial indicate that the TACT artemether-l... | [] |
NCT03355664 | 12.4.4 | Risk of phlebotomy & finger stick | The primary risks of phlebotomy include local discomfort, occasional bleeding or bruising of the skin at the site of needle puncture, and rarely haematoma or infection. | [] |
NCT03355664 | 12.5 | Benefits | Malaria is a disease that needs to be treated promptly. All patients will benefit from receiving efficacious treatment at no cost. They will be followed up closely and will be given rescue treatment if clinically indicated. | [] |
NCT03355664 | 12.6 | Alternatives to Study Participation | Patients are able to decline freely participation in this study. If so, they will receive standard care for their malaria. | [] |
NCT03355664 | 12.7 | Incentives & Compensation | Study patients or their guardian in the case of children will be compensated for time lost from work. Patients will be reimbursed for the time lost from work as a result of hospitalisation, the cost of local
transport to attend for the follow up visits and will receive a per diem to cover the costs of meals on those d... | [] |
NCT03355664 | 12.8 | Confidentiality | The trial staff will ensure that the participants' anonymity is maintained. The participants will be identified only by initials and a study number on the CRF and the MACRO EDC database. All documents will be stored securely and be accessible to trial staff and authorised personnel only. | [] |
NCT03355664 | 13 | SAMPLE SHARING AND STORAGE | Samples collected will be used for the purpose of this study as stated in the protocol and stored for future use. Consent will be obtained from patients for sample storage and/or shipment of specific samples to collaborating institutions for investigations that cannot be performed locally. Any proposed plans to use sam... | [] |
NCT03355664 | 14 | DATA HANDLING AND RECORD KEEPING | All study data will be recorded on standard Case Report Forms (CRF), at the study sites. The CRFs will be sent to the Clinical Trial Support Group, Data Management team and will be entered on the MACRO EDC database in accordance with standard operating procedures. All data management activities will be carried out to e... | [] |
NCT03355664 | 15 | SPONSORSHIP AND INSURANCE | The University of Oxford is the study sponsor and will obtain the necessary insurance. | [] |
NCT03355664 | 16 | PUBLICATION POLICY | Any data published in the peer-reviewed medical literature will protect the identity of the patients. This trial will be registered in a web based protocol registration scheme. All those who have made a substantial contribution will be co-authors on publications. The sites have the right to publish their data individua... | [] |
NCT03355664 | 17 | REFERENCES | - 1. Ashley, E.A., et al., *Spread of artemisinin resistance in Plasmodium falciparum malaria.* N Engl J Med, 2014. 371(5): p. 411-23.
- 2. Saunders, D.L., et al., *Dihydroartemisinin-piperaquine failure in Cambodia.* N Engl J Med, 2014. 371(5): p. 484-5.
- 3. Amaratunga, C., et al., *Dihydroartemisinin-piperaquine res... | [] |
NCT03355664 | 18 | APPENDIX 1. STUDY SCHEDULES D42 FOLLOW UP | [] | |
NCT03355664 | 19 | APPENDIX 2. DOSING SCHEDULES | [] | |
NCT03355664 | 19.1 | Artemether-lumefantrine | | | | Artemether-lumefantrine | | dosingschedule | | |
|----------------------|--------|-------------------------|------------------------------------------------------------|--------------------|--------------|-... | [] |
NCT03355664 | 19.2 | Amodiaquine | | | | Amodiaquine | dosing | schedule | | |
|----------------------|--------|------------------------------------------------------------|---------|-------------|---------|---------|
| | One | tabletco... | [] |
NCT03355664 | 19.3 | Primaquine | | Primaquine | dosingschedule |
|---------------------|---------------------------------|
| Weight:Kilogram | Tab/day(Tab=7.5mg) |
| tabletonday1 |
| 25-50 | 1tabletonday1 |
| >50 | 2tabletsonday1 | | [] |
NCT03355664 | 20 | APPENDIX 3. LIST OF STUDY SITES & PRINCIPAL INVESTIGATORS |
CNM: Dr Huy Rekol (Principal investigator) Dr Chea Nguon (Co-Principal Investigator) Dr Lek Dysoley (Co-Principal Investigator)
MORU : Dr. Rupam Tripura (Local investigator), Dr. James Callery (Local investigator), Dr. Tom Peto (Local investigator), Professor AM Dondorp (Principal Investigator), MORU, Thailand.
Sit... | [
"CAMBODIA",
"VIETNAM",
"Country PI:"
] |
NCT03355664 | 21 | APPENDIX 4: WWARN TERMS OF SUBMISSION |
The WWARN project (http://www.wwarn.org) is dependent on the submission of data about individual patients' responses to anti-malarial drug treatment. WWARN respects the rights of researchers and institutions who may wish to share their data with WWARN.
These terms of submission (which form part of the WWARN website'... | [
"TERMS",
"WWARN",
"DATA",
"RIGHTS",
"USE OF DATA",
"PUBLICATION OF DATA",
"YOUR CONCERNS"
] |
NCT03392532 | 1 | GLOSSARY OF TERMS | | Names of test product(s) | Throughout this document, test product will be referred to as |
|----------------------------|--------------------------------------------------------------------|
| | AOHG toric |
| ... | [] |
NCT03392532 | 2 | LIST OF ACRONYMS AND ABBREVIATIONS | Table 2–1 List of Acronyms and Abbreviations Used in This Protocol
| Abbreviation | Definition |
|--------------|------------------------------------------------------------------------|
| ADE | Adverse device effect ... | [
"P R O T O C O L S U M M A R",
"P R O T O C O L AM E N D M E N T S"
] |
NCT03392532 | 4.1 | Amendments | There are no amendments. This is the first version of the protocol. | [] |
NCT03392532 | 5 | INTRODUCTION | [] | |
NCT03392532 | 5.1 | Rationale and Background | Soft toric contact lenses were introduced into clinical practice over 40 years ago (Holden 1975) Since then, toric lens technology has continued to grow, with improvements in design, lens formulation, and reproducibility in order to enhance vision and contact lens wear experience. Patients who do not wish to wear spect... | [] |
NCT03392532 | 5.2 | Purpose of the Study | The overall purpose of this non-dispense study is to evaluate the rotational characteristics of the AOHG toric lens, by assessing lens orientation as the primary variable and comparing it to the commercially available AO toric lens.
At the end of the study, a clinical study report will be prepared in accordance with a... | [] |
NCT03392532 | 5.3 | Risks and Benefits | Contact lenses may offer improved peripheral vision and the convenience of not wearing spectacles; however, this study will only use a few select contact lens powers and subjects may require spectacles for vision correction. There is no intended clinical benefit to the subject; however, subjects will receive study visi... | [] |
NCT03392532 | 6 | STUDY OBJECTIVES | [] | |
NCT03392532 | 6.1 | Primary Objective(s) | The overall objective of the study is to evaluate the rotational characteristics of the AOHG toric lens.
Table 6–1 Primary Objective(s)
| Objective(s) | Endpoint(s) |
|------------------------------------------------|-----------------------------... | [] |
NCT03392532 | 6.2 | Secondary Objective(s) | Not applicable
D oc u me nt: Versi o n: 1 . 0 ; C U R R E N T ; M o s t - R e c e n t ; E f f e c t i v e T D O C - 0 0 5 4 4 9 9
Pa ge 2 2 of 5 4 St at us: E f f e c t i v e
 | [] |
NCT03392532 | 6 | 4 S afet y O bjecti ve(s) | Ta ble 6 – 3 S afet y O bjecti ve(s)
| [
"I N V E S TI G ATI O N A L P L A N"
] |
NCT03392532 | 7 | 1 St u d y Desi g n | T his is a pr os pecti ve, ra n d o mize d, bilateral cr oss o ver, d o u ble mas ke d , c o ntr olle d st u d y
T he st u d y p o p ulati o n will i ncl u de a p pr o xi matel y 3 5 s u bjects t o be e nr olle d at 1- 2 sites a n d will c o nsist of v ol u nteer s u bjects wit h n or mal e y es ( ot her t ha n c orre... | [
"Se q ue nce Gr o u p"
] |
NCT03392532 | 7.2 | Rationale for Study Design | In this study, the on-eye performance of the investigational AOHG toric lens and the commercially available AO toric lens will be assessed in a prospective, double-masked, bilateral crossover design with approximately 30 minutes of exposure to each study lens. The study design as well as the exposure duration of study ... | [] |
NCT03392532 | 7.3 | Rationale for Duration of Treatment/Follow-Up | The duration of exposure to the investigational products was chosen to address the objective of this study, and is aligned with AO toric fitting guidelines for initial fit assessment following lens insertion. | [] |
NCT03392532 | 7.4 | Rationale for Choice of Control Product | AO toric lenses were chosen as the control product to address the study objectives. Both AOHG toric and AO toric lenses are fluoro-silicone hydrogel lenses consisting of 33% water and 67% lotrafilcon B, and are prescribed for monthly wear. AO toric lenses are indicated for the optical correction of astigmatism of up to... | [] |
NCT03392532 | 7.5 | Data Monitoring Committee | Not applicable | [] |
NCT03392532 | 8 | STUDY POPULATION | The study population consists of adult male and female subjects (aged 18 and over) with non-diseased eyes, who require optical correction for astigmatism. It is aimed to enroll approximately 35 subjects in 1 US site, with a potential 2 nd US site being added if necessary to meet target enrollment. Site-specific targets... | [] |
NCT03392532 | 8.1 | Inclusion Criteria | Written informed consent must be obtained before any study specific assessment is performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
| 1. | Subject must be at least 18 years of age and mus... | [] |
NCT03392532 | 8.2 | Exclusion Criteria | Subjects fulfilling any of the following criteria are not eligible for participation in this study.
| 1. | Any anterior segment infection, inflammation, or abnormality or disease (including |
|-----|-----------------------------------------------------------------------------------------------------... | [] |
NCT03392532 | 8 | 3 Rescree ni n g of S u bjects | Rescree ni n g of s u bjects is n ot all o we d i n t his st u d y.
| [
"T R E A T M E N T S A D MI NI S T E R E D"
] |
NCT03392532 | 9 | 1 I n vesti g ati o n al Pro d uct(s) | Te st Pro d uct(s): AI R O P TI X pl us H Y D R A G L Y D E f or Asti g matis m
s oft c o ntact le nses
C o ntr ol Pr o d uct(s): AI R O P TI X f or Asti g matis m s oft c o ntact le nses
Ta ble 9 – 1 Te st Pro d uct
D oc u me nt: Versi o n: 1 . 0 ; C U R R E N T ; M o s t - R e c e n t ; E f f e c t i v e T D O C ... | [
"Ta ble C o ntr ol Pr o d uct"
] |
NCT03392532 | 9.2 | Other Medical Device or Medication Specified for Use During the Study | No other medical devices or medications are required to be used in conjunction with the investigational products during the clinical study. | [] |
NCT03392532 | 9.3 | Treatment Assignment / Randomization | Subjects will be randomized in a 1:1 ratio to receive treatment in crossover sequence AOHG toric then AO toric or AO toric then AOHG toric, respectively.
Only after signing the ICF, a subject will be assigned a subject number by the electronic data capture system.
A randomization list will be generated using a valida... | [] |
NCT03392532 | 9.4 | Treatment masking | This study is double-masked, with subjects randomized to use AOHG toric and AO toric lenses (in a crossover fashion) for the duration of the approximately 30 minute treatment period for each lens pair. All study team members (at the site and the Study Sponsor) are masked to the assigned sequence with the exception of t... | [] |
NCT03392532 | 9 | 5 Acc o u nt a bilit y Pr oce d ures | U p o n recei pt of t he I Ps, t he I n vesti gat or or dele gate m ust c o n d uct a n i n ve nt or y . D uri n g t he st u d y, u n mas ke d desi g nate d st u d y staff m ust pr o vi de t he I Ps t o t he s u bjects i n acc or da nce wit h t heir ra n d o mizati o n assi g n me nt. T hr o u g h o ut t he st u d y , ... | [] |
NCT03392532 | 9 | 6 C h a n ges t o c o nc o mit a nt me dic ati o ns, tr e at me nts/ pr oce d ures | C ha n ges i n c o nc o mita nt treat me nts d uri n g Vi sit are n ot all o we d u nless nee de d f or t he pr o per me dical care a n d treat me nt of t he s u bject f or a s peci fic me dical c o n diti o n.
After t he s u bject is e nr olle d i nt o t he st u d y , t he I n vesti gat or m ust i nstr uct t he s u b... | [
"1 0 S T U D Y P R O C E D U R E S A N D A S S E S S M E N T S"
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.