Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN® In The Treatment of Chronic Open-Angle Glaucoma

NCT04890106 | Completed Phase 3 FDA Drug

• 1 other identifier: CBCC/2021/004
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 9

Brief Summary

This is a randomized, double-masked, 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 Mankind Pharma Limited, India Reference Product - LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc.,

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points

  Change in mean difference in intraocular pressure (IOP) of both the eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.

  Day 14 and 42 at 00.00 hours (between 8:00 AM and 10:00 AM), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours)

Secondary Outcomes (1)

• Safety and efficacy of Bimatoprost 0.01% Ophthalmic Solution

  Safety will be evaluated throughout the study (6 weeks) and telephonic safety follow-up on day 49±3 days

Study Arms (2)

Bimatoprost 0.01% Ophthalmic Solution

EXPERIMENTAL

Bimatoprost Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Mankind Pharma Limited, India. Intervention Drug: Test - Bimatoprost 0.01% Ophthalmic Solution

Drug: Test - Bimatoprost 0.01% Ophthalmic Solution

LUMIGAN® 0.01% Ophthalmic Solution

ACTIVE COMPARATOR

LUMIGAN® ( Contains Bimatoprost) Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Allergan, Inc., Intervention Drug: Reference - Bimatoprost 0.01% Ophthalmic Solution

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 ± 2 hours for 42 days.

Bimatoprost 0.01% Ophthalmic Solution

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

Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours 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 the protocol requirements
• Male or non-pregnant females aged ≥18 years having body mass index (BMI) ≥ 17 calculated as weight in kg/height in m2.
• Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
• Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo an appropriate washout period
• Adequate wash-out period prior to baseline of any ocular hypotensive medication as per the table below (In order 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 subjects must have discontinued all ocular hypotensive medications for the minimum washout period
• Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and difference in IOP between the eyes is not greater than 5 mm Hg
• Subject's IOP is likely to be controlled with monotherapy as per the discretion of the investigator
• Baseline best-corrected visual acuity equivalent to 20/200 (6/60) or better in each eye
• Women of child-bearing potential (defined as women physiologically capable of becoming pregnant, unless they are using an effective contraception method during dosing of the investigational product) practicing any two acceptable contraception methods
• Acceptable methods of contraception are:
• Oral or parenteral (injection) , patch, or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
• Intrauterine device (IUD) or intrauterine system IUS)
• A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
• Male sterilization (at least six months prior to the screening, should be the sole male partner for that subject)
• Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least six weeks prior to study participation

You may not qualify if:

• Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients of the formulation
• Severe hepatic or renal impairment
• Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer
• Functionally significant visual field loss
• Use of an intraocular corticosteroid implant at any time prior to the baseline
• Use of contact lens within one week prior to the baseline
• Use of 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid within two weeks prior to the baseline
• Use of 1) systemic corticosteroid or 2) high-dose salicylate therapy defined as 325mg/day taken on three consecutive days, within one month prior to the baseline
• Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six months prior to the baseline
• Underwent any other intraocular surgery (e.g., cataract surgery) within six months prior to the baseline
• Underwent refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty) within twelve months prior to the baseline
• Amblyopia/only one sighted eye
• Subjects with a past history of IOP previously uncontrolled on bimatoprost monotherapy
• Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8, split fixation, or functionally significant (in the investigators' opinion) visual field loss
• Chronic use of any systemic medication that may affect IOP with less than a three-month stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)

Sponsors & Collaborators

• Mankind Pharma Limited: lead
• CBCC Global Research: collaborator

Study Sites (9)

CBCC Global Research Site:011

Bakersfield, California, 93308, United States

Location

CBCC Global Research Site 016

Mission Hills, California, 91345, United States

Location

CBCC Global Research Site 017

Newport Beach, California, 92663, United States

Location

CBCC Global Research Site: 012

Newport Beach, California, 92663, United States

Location

CBCC Global Research Site 013

Pasadena, California, 91107, United States

Location

CBCC Global Research Site 019

Petaluma, California, 94954, United States

Location

CBCC Global Research Site 015

San Diego, California, 92122, United States

Location

CBCC Global Research Site 020

Pembroke Pines, Florida, 33029, United States

Location

CBCC Global Research Site 018

Houston, Texas, 77008, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Ophthalmic Solutions; Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: October 2, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (9)