Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.

NCT05401357 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CBCC/2021/025
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 9

Brief Summary

This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Keywords

Bimatoprost ophthalmic solution 0.01% in both eyes; Chronic open-angle glaucoma in both eyes

Outcome Measures

Primary Outcomes (1)

• Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.

  Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits

  Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.

Secondary Outcomes (1)

• AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%

  AE Monitoring for Safety will be evaluated throughout the study for 6 weeks.

Study Arms (2)

Bimatoprost 0.01% Ophthalmic Solution

EXPERIMENTAL

Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.

Drug: Test - Bimatoprost 0.01% Ophthalmic Solution

LUMIGAN® 0.01% Ophthalmic Solution

ACTIVE COMPARATOR

Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.

Drug: Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

Interventions

Test - Bimatoprost 0.01% Ophthalmic Solution DRUG

Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.

Bimatoprost 0.01% Ophthalmic Solution

Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) DRUG

Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.

LUMIGAN® 0.01% Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
• Male or females aged ≥18 years.
• Subjects having body mass index (BMI) ≥18.50 kg/m2.
• 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 per the table below (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 \<35 mm Hg in each eye,
• 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

You may not qualify if:

• Female who are pregnant, lactating or planning a pregnancy.
• Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
• Current or past history of severe hepatic or renal impairment.
• Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
• Functionally significant visual field loss in the Investigators' opinion.
• Subject with corneal grafts.
• Subject has contraindication to pupil dilation
• Use at any time prior to baseline of an intraocular corticosteroid implant
• Use of contact lens within 1 week prior to baseline
• Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid
• Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high dose salicylate therapy defined as 325 mg/day and taken on 3 consecutive days.
• Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid
• Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
• Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
• Amblyopia - only one sighted eye.

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• CBCC Global Research: collaborator

Study Sites (9)

Eye Research Foundation Inc.

Newport Beach, California, 92663, United States

RECRUITING

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

RECRUITING

Volusia Eye Associates

New Smyrna Beach, Florida, 32169, United States

RECRUITING

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

RECRUITING

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

RECRUITING

Toyos Clinic

Nashville, Tennessee, 37215, United States

RECRUITING

Keystone Research

Austin, Texas, 78731, United States

NOT YET RECRUITING

Houston Eye Associates, North Loop

Houston, Texas, 77008, United States

RECRUITING

Cheyenne Eye Clinic & Surgery Center

Cheyenne, Wyoming, 82001, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Ophthalmic Solutions; Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Ilesh Changela, MBBS; MD

CONTACT

+91-79-67778300; ilesh@amnealindia.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double-blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either group

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: June 2, 2022
• Study Start: June 29, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)