Clinical trial NCT03965052: Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®
Official title: Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®, on the Ocular Surface of Clinically Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma
Keywords: Travoprost
ophthalmic solution
Prostaglandin Analogues
Antiglaucoma drugs
glaucoma
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, with randomization.
Primary purpose: TREATMENT

Brief summary: Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.

Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.

Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.

Detailed description: Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.

duration: 10 days.

Duration of subject in the study: 15 to 22 days.

Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.

The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).

Statistical methodology:

The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2) or Fisher's exact. An alpha ≤ 0.05 will be considered significant.

Eligibility criteria: Inclusion Criteria:

* Be clinically healthy.
* Have the ability to give their signed informed consent and show willingness to comply with the study procedures
* Have an age between 18 to 45 years.
* Indistinct sex.
* Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
* Present blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.

Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.

* Blood chemistry of three elements (QS): Glucose, urea and creatinine.
* Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.

  * Present visual ability 20/30 or better in both eyes.
  * Present vital signs within normal parameters.
  * Present intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

* Be a user of topical ophthalmic products of any kind.
* Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
* In case of being a woman, being pregnant or breastfeeding.
* Have participated in clinical research studies 90 days prior to inclusion in the present study.
* Have previously participated in this same study.
* Be a user of contact lenses and can not suspend their use during the study.
* That they can not follow the lifestyle considerations described in section 6.2.2
* Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.
* Having a history of any chronic-degenerative disease.
* Present inflammatory or infectious disease, active at the time of admission to the study.
* Present injuries or unresolved traumas at the time of entering the study.
* Having the antecedent of any type of eye surgery.
* Having undergone surgical procedures, not ophthalmological, in the last 3 months.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: during the 14 days of evaluation, including the safety call (day 14).
measure: Eye Comfort Index
timeFrame: will be evaluated at the end of the treatment, at the final visit (day 11)
Secondary outcomes:
measure: Number of Eyes With Epithelial Defects by Grade
timeFrame: will be evaluated at the end of the treatment, at the final visit (day 11)
measure: Visual Ability
timeFrame: will be evaluated at the end of the treatment, at the final visit (day 11)
measure: Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
timeFrame: will be evaluated at the end of the treatment, at the final visit (day 11)
measure: Number of Eyes of Chemosis
timeFrame: will be evaluated at the end of the treatment, at the final visit (day 11)
Other outcomes:
measure: Changes in Intraocular Pressure
timeFrame: will be evaluated at the end of the treatment, at the final visit (day 11)
Locations:
city: Guadalajara
country: Mexico
facility: Jose Navarro Partida
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo Baiza Durán, MD
role: STUDY_DIRECTOR
References:
citation: Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.