Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

NCT02097719 | Completed Phase 4 Results

• 1 other identifier: GMA-LUM-12-022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM

  IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.

  Week 12 at 8 AM, 12 PM, and 4 PM

Study Arms (2)

bimatoprost 0.01% and hypromellose 0.3%

ACTIVE COMPARATOR

Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.

Drug: bimatoprost 0.01%; Drug: hypromellose 0.3%

travoprost 0.004% and timolol 0.5%

ACTIVE COMPARATOR

Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.

Drug: travoprost 0.004%; Drug: timolol 0.5%

Interventions

bimatoprost 0.01% DRUG

Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.

Also known as: Lumigan® RC, Lumigan®

bimatoprost 0.01% and hypromellose 0.3%

travoprost 0.004% DRUG

Travoprost 0.004% administered to both eyes once daily for 12 weeks.

Also known as: Travatan Z®

travoprost 0.004% and timolol 0.5%

timolol 0.5% DRUG

Timolol 0.5% administered to both eyes once daily for 12 weeks.

Also known as: Timolol Maleate-EX, Timolol GFS

travoprost 0.004% and timolol 0.5%

hypromellose 0.3% DRUG

Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Also known as: GenTeal®

bimatoprost 0.01% and hypromellose 0.3%

Eligibility Criteria

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

You may qualify if:

• Ocular hypertension or glaucoma that requires treatment with medication
• Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

You may not qualify if:

• History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
• History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
• Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Racine, Wisconsin, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Bimatoprost; Travoprost; Timolol; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

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; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 27, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

US (1)