anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Immediate post-placental placement of the levonorgestrel IUD

Levonorgestrel IUD: Timing of IUD insertion
Eligibility criteria:
Inclusion Criteria:

Healthy, 18-40 year old pregnant women
Intend to breastfeed
Desire the LNG IUD as their method of contraception
Agree to be randomized to early versus standard postpartum insertion
Have delivered a healthy term infant (37 weeks gestation)
Willing to complete all study related procedures, visits and questionnaires

Exclusion Criteria:

Chorioamnionitis
Obstetric complications including transfusion
Severe pregnancy induced hypertension
Prolonged hospitalization
Coagulopathy
Liver disease
Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 138
Group description: Placement of the levonorgestrel IUD 4-6 weeks postpartum

Levonorgestrel IUD: Timing of IUD insertion
Eligibility criteria:
Inclusion Criteria:

Healthy, 18-40 year old pregnant women
Intend to breastfeed
Desire the LNG IUD as their method of contraception
Agree to be randomized to early versus standard postpartum insertion
Have delivered a healthy term infant (37 weeks gestation)
Willing to complete all study related procedures, visits and questionnaires

Exclusion Criteria:

Chorioamnionitis
Obstetric complications including transfusion
Severe pregnancy induced hypertension
Prolonged hospitalization
Coagulopathy
Liver disease
Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Cyclosporine
Eligibility criteria:
Inclusion Criteria:

age > 18
able to give consent
commitment to return for follow up appointments
agree to all parts of the study, including pain sensation testing
total Interstitial Cystitis Symptom Index (ICSI) score >9

Exclusion Criteria:

active cancer
history of pelvic radiation
history of previous urological malignancy
serum Cr > 1.5 mg/dl
diagnosis of diabetes mellitus types I or II
untreated hypertension or blood pressure on treatment > 140/90
proteinuria at enrollment
current or previous urinary diversion or bladder augmentation
chronic use of a medication class with significant impact on Cyclosporine A (CyA) blood levels (eg. macrolide antibiotics, phenytoin, oral antifungals, calcium channel blockers)
untreated urinary tract infection
pregnant or breast feeding
neurological impairment or spinal cord injury
known hypersensitivity to CyA
concurrent use of another immunosuppressive drug (eg. oral corticosteroids, tacrolimus, mycophenolate mofetil)
Intervention: Fludarabine
Trial phase: Phase 2
ATC code: L01BB05
SMILES: Nc1nc(F)nc2c1ncn2C1OC(CO)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Fludarabine, Total Body Irradiation (TBI)

Fludarabine

Total Body Irradiation
Eligibility criteria:
Inclusion Criteria:

Disease Criteria:

ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration.
Philadelphia chromosome positive ALL is allowed.
Lymphoid blastic crisis of CML will be included (provided that patients achieve CR).
Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.
Organ Function Criteria: All organ function testing should be done within 28 days of study registration.
Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted.
Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:

CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).

Hepatic:

Serum bilirubin 2.0 g/dL
Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN
Alkaline phosphatase 2.5 ULN
Performance status: Karnofsky ≥ 70%
Consent: Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability,in the opinion of the principal investigator, to comply with all the requirements of the study.
Presence of a willing adult HLA-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors will be evaluated for eligibility and suitability per the standard of care according to the FACT and NMDP guidelines.

Exclusion Criteria:

Non-compliant to medications.
No appropriate caregivers identified.
HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
Active life-threatening cancer requiring treatment other than ALL
Uncontrolled medical or psychiatric disorders.
Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration.
Active central nervous system (CNS) leukemia
Preceding allogeneic HSCT
Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed.
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 240
Group description: Bupivicaine 5 mg
Eligibility criteria:
Inclusion Criteria:

Healthy patients age 18 and older
Breech presentation
Singleton gestation .scheduled for ECV desiring CSE.

Exclusion Criteria:

Refusal
Contraindication to neuraxial (coagulopathy, anticoagulant use, local infection, sepsis etc) .Rupture of membranes.
Drop-out: Patients may choose to drop-out of the study at any time. The physicians involved in this study may choose to end a patient's involvement in the study at their discretion.
Intervention: Ticagrelor
Trial phase: Phase 3
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9562
Group description: Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Eligibility criteria:
Inclusion Criteria:

Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

Key Exclusion Criteria:

History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis
Intervention: Amisulpride
Trial phase: Phase 3
ATC code: N05AL05
SMILES: CCN1CCCC1CNC(=O)c1cc(S(=O)(=O)CC)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 169
Group description: APD421 at 5mg given by single intravenous (IV) administration, by slow push over one to two minutes at induction of anaesthesia.
Eligibility criteria:
Inclusion Criteria:

Male or female patients ≥ 18 years of age
Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria:

Patients scheduled for outpatient/day case surgery
Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
Patients who are expected to remain ventilated for a period after surgery
Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
Intervention: Clotrimazole
Trial phase: Phase 3
ATC code: A01AB18 | D01AC01 | G01AF02 | G01AF20
SMILES: Clc1ccccc1C(c1ccccc1)(c1ccccc1)n1ccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 190
Group description: Five drops into the ear canal twice daily for 14 days

Clotrimazole: Five drops into the ear canal twice daily for 14 days
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Clinical diagnosis of otomycosis where topical treatment is indicated.

Exclusion Criteria:

Other ear diseases.
Intervention: Acetylcysteine
Trial phase: Phase 3
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 1200 mg twice daily dosing for 8 weeks

N-Acetylcysteine (NAC)
Eligibility criteria:
Inclusion Criteria:

1. Age 18-30 2. Fingernail biter for ≥5 years

Exclusion Criteria:

1. Any unstable major DSM-IV Axis I psychiatric disorder in the past month (e.g., psychotic disorders, bipolar disorder, major depressive disorder) 2. Current substance dependence in the past month 3. Current unstable major medical disorder or medical condition in the past 6 months (e.g., renal impairment) 4. Current pregnancy or breastfeeding 5. Current seizure disorder or asthma, due to possible elevated risk for adverse effects with NAC in individuals with these conditions 6. Known hypersensitivity to NAC 7. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.
Eligibility criteria:
Inclusion Criteria:

Medically-confirmed diagnosis of chronic idiopathic constipation
Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

Exclusion Criteria:

Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Intervention: Naldemedine
Trial phase: Phase 3
ATC code: A06AH05
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CC(C(=O)NC(C)(C)c1nc(-c3ccccc3)no1)=C2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 271
Group description: Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18 to 80 years inclusive at the time of informed consent
Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)
Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration
Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary

Exclusion Criteria:

Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
Evidence of active medical diseases affecting bowel transit
History or presence of pelvic disorders that may be a cause of constipation
Surgery (except for minor procedures) within 60 days of Screening
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)
Subjects who have never taken laxatives for the treatment of OIC
History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer
Current use of any prohibited medication including opioid antagonists, partial agonists, or mixed agonists/antagonists
Intervention: Colchicine
Trial phase: Phase 4
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: 500 mcg every eight hours for four days

Low-dose colchicine: Route of Administration: Tablet - Oral Use

Dose: 500 mcg (one tablet) every eight hours for four days
Eligibility criteria:
Inclusion Criteria:

Adults aged 18 years and over
Consultation with GP, primary care out-of-hours service or walk-in-centre
Current attack of acute gout (first attack or recurrent).
Patient has capacity and willingness to give consent and complete the trial paperwork

Exclusion Criteria:

Known unstable medical conditions (such as ischaemic heart disease, impaired liver function)
Known stage 4/5 kidney disease (eGFR/creatinine clearance <30ml/min)
Recent surgery or gastrointestinal bleed
History of gastric ulcer
Current anticoagulant use
Allergy to aspirin/NSAID
Previous inability to tolerate naproxen or low-dose colchicine
Other contraindication to either study drug in accordance with the Summary of Product Characteristics (SPC)
Prescription of naproxen or colchicine in the previous 24 hours
Pregnant or lactating females
Potentially vulnerable
Previous participation in the CONTACT trial during a previous acute attack of gout.
Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days
Intervention: Trexima
Trial phase: Phase 4
SMILES: CNS(=O)(=O)Cc1ccc2[nH]cc(CCN(C)C)c2c1.COc1ccc2cc(C(C)C(=O)[O-])ccc2c1.O=C(O)CCC(=O)O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days

Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use

Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days
Eligibility criteria:
Inclusion Criteria:

Adults aged 18 years and over
Consultation with GP, primary care out-of-hours service or walk-in-centre
Current attack of acute gout (first attack or recurrent).
Patient has capacity and willingness to give consent and complete the trial paperwork

Exclusion Criteria:

Known unstable medical conditions (such as ischaemic heart disease, impaired liver function)
Known stage 4/5 kidney disease (eGFR/creatinine clearance <30ml/min)
Recent surgery or gastrointestinal bleed
History of gastric ulcer
Current anticoagulant use
Allergy to aspirin/NSAID
Previous inability to tolerate naproxen or low-dose colchicine
Other contraindication to either study drug in accordance with the Summary of Product Characteristics (SPC)
Prescription of naproxen or colchicine in the previous 24 hours
Pregnant or lactating females
Potentially vulnerable
Previous participation in the CONTACT trial during a previous acute attack of gout.
Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Retrobulbar anesthesia with Bupivicaine Hydrochloride

Bupivicaine Hydrochloride: Retrobulbar anesthesia
Eligibility criteria:
Inclusion Criteria:

Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery Center and Emory University Hospital by retina attending faculty surgeons

Exclusion Criteria:

Unable to verbalize level of pain control
Pediatric patients (<18 years old)
Glaucoma, ocular hypertension, or glaucoma suspects
Allergy to local anesthetic
Pre-existing chronic pain requiring narcotic pain medication
Drug addiction
Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)
Intervention: CID 168324442
Trial phase: Phase 1
SMILES: CCC(C)C(N=C(O)CN)C(O)=NC(C(O)=NC(CCC(=O)O)C(O)=NC(CCC(=N)O)C(O)=NC1CSSCC2N=C(O)C(C(C)CC)N=C(O)C(CO)N=C(O)C(C(C)O)N=C(O)C(CSSCC3N=C(O)C(CC(C)C)N=C(O)C(Cc4cnc[nH]4)N=C(O)C(CCC(=N)O)N=C(O)C(CC(=N)O)N=C(O)C(C(C)C)N=C(O)C(Cc4ccccc4)N=C(O)C(CC(=N)O)N=C(O)C(CSSCC(C(O)=NCC(O)=NC(CCC(=O)O)C(O)=NC(CCCNC(=N)N)C(O)=NCC(O)=NC(Cc4ccccc4)C(O)=NC(Cc4ccccc4)C(O)=NC(Cc4ccc(O)cc4)C(O)=NC(C(O)=NC(CCCCN=C(O)OCCOC)C(=O)N4CCCC4C(O)=NC(C(=O)O)C(C)O)C(C)O)N=C(O)C(C(C)C)N=C(O)C(CC(C)C)N=C(O)C(Cc4ccc(O)cc4)N=C(O)C(CC(C)C)N=C(O)C(C)N=C(O)C(CCC(=O)O)N=C(O)C(C(C)C)N=C(O)C(CC(C)C)N=C(O)C(Cc4cnc[nH]4)N=C(O)C(CO)N=C(O)CN=C3O)N=C(O)C(Cc3ccc(O)cc3)N=C(O)C(CC(=N)O)N=C(O)C(CCC(=O)O)N=C(O)C(CC(C)C)N=C(O)C(CCC(=N)O)N=C(O)C(Cc3ccc(O)cc3)N=C(O)C(CC(C)C)N=C(O)C(CO)N=C2O)N=C1O)C(C)C
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Eligibility criteria:
Inclusion Criteria:

Participants are overtly healthy male Japanese.
Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m^2), inclusive.

Exclusion Criteria:

Participants have known allergies to insulin peglispro or related compounds.
Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL) (>6 millimoles per liter [mmol/L]).
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Oxytocin 15 mcg injected spinally

Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally
Eligibility criteria:
Inclusion Criteria:

healthy
weight < 240 pounds
American Society of Anesthesiology Category 1 or 2

Exclusion Criteria:

allergy to oxytocin or lidocaine
allergy to chilli peppers
Females: active gynecological disease such as uterine fibroids or ongoing bleeding
Pregnancy or currently breastfeeding
Females that have delivered a baby within 2 years of study
Taking prescription medications (exception: oral birth control medication)
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Oxytocin 150 mcg injected spinally

Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally
Eligibility criteria:
Inclusion Criteria:

healthy
weight < 240 pounds
American Society of Anesthesiology Category 1 or 2

Exclusion Criteria:

allergy to oxytocin or lidocaine
allergy to chilli peppers
Females: active gynecological disease such as uterine fibroids or ongoing bleeding
Pregnancy or currently breastfeeding
Females that have delivered a baby within 2 years of study
Taking prescription medications (exception: oral birth control medication)
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 171
Group description: Loteprednol Etabonate Gel 0.38% administered two times daily (BID).

Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
Eligibility criteria:
Inclusion Criteria:

Visit 1 (Screening Visit)

Be willing and able to comply with all treatment and follow-up/study procedures.
Be a candidate for routine, uncomplicated cataract surgery

Visit 3 (Postoperative Day 1)

Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Have known hypersensitivity or contraindication to the study drug(s) or their components.
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: Loteprednol Gel 0.38% administered three times daily (TID).

Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
Eligibility criteria:
Inclusion Criteria:

Visit 1 (Screening Visit)

Be willing and able to comply with all treatment and follow-up/study procedures.
Be a candidate for routine, uncomplicated cataract surgery

Visit 3 (Postoperative Day 1)

Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Have known hypersensitivity or contraindication to the study drug(s) or their components.