A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

NCT06267274 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MW230021
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Open-angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Mean difference in the IOP of both eyes between the two treatment groups at 3 time points

  00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits

Secondary Outcomes (1)

• Secondary Endpoint

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

Study Arms (2)

Bimatoprost Ophthalmic Solution, 0.01%

EXPERIMENTAL

Test Product: Bimatoprost Ophthalmic Solution, 0.01%

Drug: Bimatoprost Ophthalmic Solution, 0.01%

LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

ACTIVE COMPARATOR

Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

Drug: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

Interventions

Bimatoprost Ophthalmic Solution, 0.01% DRUG

1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.

Bimatoprost Ophthalmic Solution, 0.01%

LUMIGAN® (bimatoprost ophthalmic solution) 0.01% DRUG

1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.

LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

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 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

You may not qualify if:

• Female who are pregnant, lactating or planning a pregnancy.
• Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
• Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
• Current or 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).

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• CBCC Global Inc.: collaborator
• Amneal EU, Limited: collaborator

Study Sites (4)

West Coast Eye Institute

Bakersfield, California, 93308, United States

RECRUITING

Eye Research Foundation

Newport Beach, California, 92663, United States

RECRUITING

Clayton Eye Research

Morrow, Georgia, 30260, United States

RECRUITING

Houston Eye Associates

Houston, Texas, 77008, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

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, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)