A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

NCT02061683 | Completed Phase 4 Results

• 1 other identifier: CN-BIM-0901
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) in the Study Eye

  IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).

  Month 3

Secondary Outcomes (1)

• Percentage of Patients With an Adverse Event of Conjunctival Hyperemia

  3 Months

Study Arms (1)

Bimatoprost 0.03%

EXPERIMENTAL

Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Drug: Bimatoprost 0.03%

Interventions

Bimatoprost 0.03% DRUG

Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Also known as: LUMIGAN®

Bimatoprost 0.03%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of open-angle glaucoma or ocular hypertension
• No use of Lumigan® in the past 3 months

You may not qualify if:

• Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Shanghai, China

Location

Related Publications (1)

• Wang K, Xu L, Yuan Z, Yao K, Zhao J, Xu L, Fang A, Zhang M, Wu L, Ji J, Hou J, Liu Q, Sun X. Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China. BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.

  PMID: 24568617 BACKGROUND

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

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: April 19, 2010
• Primary Completion: June 24, 2011
• Study Completion: June 24, 2011
• Last Updated: April 18, 2019
• Results First Posted: June 18, 2014

Record last verified: 2019-04

Locations

CN (1)