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

Last updated: August 5, 2024
Sponsor: Amneal Pharmaceuticals, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Williams Syndrome

Circulation Disorders

Vascular Diseases

Treatment

Bimatoprost Ophthalmic Solution, 0.01%

LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

Clinical Study ID

NCT06267274
MW230021
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects willing and able to provide voluntary informed consent and to followprotocol requirements.

  2. Male or females aged ≥18 years.

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

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

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

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

  7. Subjects' IOP is likely to be controlled with monotherapy as per the Investigator'sdiscretion.

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

  9. Women of childbearing potential (defined as women physiologically capable ofbecoming pregnant unless they are using an effective method of contraception duringthe dosing of the study drug) practicing any of the following acceptable methods ofcontraception:

  10. Oral or parenteral (injection, patch, or implant) hormonal contraception whichhas been continuously used for at least 1 month prior to first dose of studymedication.

  11. Intrauterine device (IUD) or intrauterine system (IUS)

  12. Double barrier method of contraception (condom and occlusive cap or condom andspermicidal agent)

  13. Male sterilization (at least 6 months prior to screening, should be the solemale partner for that subject)

  14. Female sterilization (surgical bilateral oophorectomy) or tubal ligation atleast 6 weeks prior to study participation

  15. Total abstinence; partial abstinence is not acceptable

  16. No history of addiction to any recreational drug or drug dependence or alcoholaddiction

Exclusion

Exclusion Criteria:

  1. Female who are pregnant, lactating or planning a pregnancy.

  2. Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and whoare treatment naive.

  3. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs,or any of the excipients of formulation.

  4. Current or history of severe hepatic or renal impairment.

  5. Current or history within 2 months prior to baseline of any other significant oculardisease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in eithereye (Note: stable myopia, strabismus, and cataracts as per the Investigator'sdiscretion will be allowed provided that the other inclusion/exclusion criteria aremet).

  6. Current corneal abnormalities that would prevent accurate IOP readings with Goldmannapplanation tonometer.

  7. Functionally significant visual field loss in the Investigators' opinion.

  8. Subject with corneal grafts.

  9. Subject has contraindication to pupil dilation.

  10. Use at any time prior to baseline of an intraocular corticosteroid implant.

  11. Use of contact lens within 1 week prior to baseline.

  12. Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2)a topical corticosteroid.

  13. Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high-dosesalicylate therapy defined as 325 mg/day and taken on 3 consecutive days.

  14. Use within 6 months prior to baseline of intravitreal or subtenon injection of anophthalmic corticosteroid.

  15. Underwent within 6 months prior to baseline any other intraocular surgery (e.g.,cataract surgery).

  16. Underwent within 12 months prior to baseline any refractive surgery, filteringsurgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).

  17. Amblyopia - only one sighted eye.

  18. Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy.

  19. Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater)in either eye found on gross macroscopic or slit lamp examination.

  20. Severe retinal disease or other severe ocular pathology, such as glaucomatous damagewith a cup/disk ratio greater than 0.8 (not including physiological cupping in theInvestigators' opinion) or split fixation.

  21. Chronic use of any systemic medication that may affect IOP with less than 3 monthsstable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blockingagents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers,angiotensin-converting enzyme inhibitors, etc.)

  22. Central Corneal thickness (CCT) <450 microns or >650 microns.

  23. Known history or presence of any uncontrolled systemic disease (e.g., cardiovasculardisease, hypertension, diabetes mellitus, hepatic impairment, etc.)

  24. History of recurrent ocular seasonal allergies within the past 2 years.

  25. Any other medical condition or serious intercurrent illness that, in theInvestigator's opinion, may make it undesirable for the subject to participate inthe study and would limit adherence to the study requirements.

  26. Participation in any clinical study within 30 days before the first dose of thestudy drug.

  27. Subjects with known history of positive serology for Hepatitis B Virus (HBV),Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.

  28. Subjects with positive urine pregnancy test.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Bimatoprost Ophthalmic Solution, 0.01%
Phase: 1
Study Start date:
April 01, 2024
Estimated Completion Date:
May 01, 2025

Study Description

Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes who meet all of the inclusion criteria and none of the exclusion criteria will be identified.

Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug. They will undergo a washout period of 4 days to 4 weeks (28 days) based on their current medication (if available). Based on stratification criteria, IOP and CCT information available at baseline visit for each subject, the 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. The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points, i.e., at 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.

The Secondary Endpoint: the incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events.

Connect with a study center

  • West Coast Eye Institute

    Bakersfield, California 93308
    United States

    Active - Recruiting

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Clayton Eye Research

    Morrow, Georgia 30260
    United States

    Active - Recruiting

  • Houston Eye Associates

    Houston, Texas 77008
    United States

    Active - Recruiting

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