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.

Last updated: August 9, 2022
Sponsor: Amneal Pharmaceuticals, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Ocular Hypertension

Stress

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT05401357
CBCC/2021/025
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects willing and able to provide voluntary informed consent and to follow protocolrequirements.
  • 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 allocular hypotensive medication(s) or switch ocular hypotensive medications and undergoappropriate washout period.
  • Adequate washout period prior to baseline of any ocular hypotensive medications as perthe table below (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitutea parasympathomimetic 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.
  • 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'sdiscretion.
  • Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or betterin each eye, using a logarithmic visual acuity chart for testing at 10 feet (3meters).
  • Women of childbearing potential (defined as women physiologically capable of becomingpregnant unless they are using an effective method of contraception during the dosingof the study drug) practicing any of the following acceptable methods ofcontraception:
  1. Oral or parenteral (injection, patch, or implant) hormonal contraception whichhas been continuously used for at least 1 month prior to first dose of studymedication
  2. Intrauterine device (IUD) or intrauterine system (IUS)
  3. Double barrier method of contraception (condom and occlusive cap or condom andspermicidal agent)
  4. Male sterilization (at least 6 months prior to screening, should be the sole malepartner for that subject)
  5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
  6. Total abstinence; partial abstinence is not acceptable
  • No history of addiction to any recreational drug or drug dependence or alcoholaddiction.

Exclusion

Exclusion Criteria:

  • Female who are pregnant, lactating or planning a pregnancy.
  • Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, orany of the excipients of formulation.
  • Current or past history of severe hepatic or renal impairment.
  • 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).
  • Current corneal abnormalities that would prevent accurate IOP readings with Goldmannapplanation 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) atopical corticosteroid
  • 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.
  • Use within 6 months prior to baseline of intravitreal or subtenon injection of anophthalmic 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, filteringsurgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
  • Amblyopia - only one sighted eye.
  • Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy
  • Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater)in either eye found on gross macroscopic or slit lamp examination
  • 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
  • Chronic use of any systemic medication that may affect IOP with less than 3 monthsstable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents,alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers,angiotensin-converting enzyme inhibitors, etc.)
  • Central Corneal thickness (CCT) <450 microns or >650 microns
  • Known history or presence of any uncontrolled systemic disease (e.g., cardiovasculardisease, hypertension, diabetes mellitus, hepatic impairment, etc.)
  • History of recurrent ocular seasonal allergies within the past 2 years
  • Any other medical condition or serious intercurrent illness that, in theInvestigator's opinion, may make it undesirable for the subject to participate in thestudy and would limit adherence to the study requirements
  • Participation in any clinical study within 90 days before the first dose of the studydrug
  • Subjects with documented history of positive serology for Hepatitis B Virus (HBV),Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection
  • Subjects with positive urine pregnancy test
  • Subjects with confirmed novel coronavirus infection (COVID-19).

Study Design

Total Participants: 168
Study Start date:
June 29, 2022
Estimated Completion Date:
December 31, 2022

Study Description

Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. At baseline (Day 0), subjects qualifying Intra Ocular Pressure (IOPs) following wash-out, with difference between the IOP in left and right eyes not being more than 5 mm Hg, will be randomized.

Subjects will instill 1 drop of study drug (either T or R) in both eyes every evening at approximately 10:00 pm for 42 days.

The study subjects will undergo clinical evaluations throughout the study in order to assess safety and efficacy. Primary endpoint evaluation will be assessed after 2 weeks (Day 14) and 6 weeks (Day 42) of treatment for each study subject deemed eligible for evaluation.

The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups.

Connect with a study center

  • Eye Research Foundation Inc.

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • North Bay Eye Associates, Inc.

    Petaluma, California 94954
    United States

    Active - Recruiting

  • Volusia Eye Associates

    New Smyrna Beach, Florida 32169
    United States

    Active - Recruiting

  • Clayton Eye Clinical Research, LLC

    Morrow, Georgia 30260
    United States

    Active - Recruiting

  • Coastal Research Associates, LLC

    Roswell, Georgia 30076
    United States

    Active - Recruiting

  • Toyos Clinic

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Houston Eye Associates, North Loop

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Cheyenne Eye Clinic & Surgery Center

    Cheyenne, Wyoming 82001
    United States

    Active - Recruiting

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