A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.

• Male or females aged ≥18 years.

• Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes

• Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

• Adequate washout period prior to baseline of any ocular hypotensive medications as (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period .

• Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<28 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg

• Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.

• Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).

• Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception:

∙ Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.

‣ Intrauterine device (IUD) or intrauterine system (IUS)

‣ Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)

‣ Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)

‣ Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation

‣ Total abstinence; partial abstinence is not acceptable

⁃ No history of addiction to any recreational drug or drug dependence or alcohol addiction

Locations
United States
California
West Coast Eye Institute
RECRUITING
Bakersfield
Eye Research Foundation
RECRUITING
Newport Beach
Georgia
Clayton Eye Research
RECRUITING
Morrow
Texas
Houston Eye Associates
RECRUITING
Houston
Contact Information
Primary
Ilesh Changela, MD
ilesh@amneal.com
+91-79-67778300
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 240
Treatments
Experimental: Bimatoprost Ophthalmic Solution, 0.01%
Test Product: Bimatoprost Ophthalmic Solution, 0.01%
Active_comparator: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
Sponsors
Collaborators: CBCC Global Inc., Amneal EU, Limited
Leads: Amneal Pharmaceuticals, LLC

This content was sourced from clinicaltrials.gov

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