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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-08-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Bimatoprost Ophthalmic Solution, 0.01%

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.

DRUG

LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

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.

Sponsors & Collaborators

  • CBCC Global Inc.

    collaborator UNKNOWN

  • Amneal EU, Limited

    collaborator UNKNOWN

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-03-01
Completion
2025-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267274 on ClinicalTrials.gov