Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

NCT01547598 | Completed Phase 4 Results

• 1 other identifier: GMA-LUM-11-020
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Diurnal Intraocular Pressure (IOP)

  IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.

  Week 12

Secondary Outcomes (4)

• Change From Baseline in Mean IOP at Week 12

  Baseline, Week 12

• Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline

  Baseline, Week 12

• Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg

  Week 12

• Change From Baseline in Mean IOP at Week 6

  Baseline, Week 6

Study Arms (2)

LUMIGAN® RC

ACTIVE COMPARATOR

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Drug: travoprost ophthalmic solution 0.004%; Drug: Bimatoprost ophthalmic solution 0.01%

DuoTrav®

ACTIVE COMPARATOR

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.

Drug: travoprost ophthalmic solution 0.004%; Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution

Interventions

travoprost ophthalmic solution 0.004% DRUG

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.

Also known as: Travatan® Z

DuoTrav®; LUMIGAN® RC

travoprost 0.004% / timolol 0.5% combination ophthalmic solution DRUG

DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.

Also known as: DuoTrav®

DuoTrav®

Bimatoprost ophthalmic solution 0.01% DRUG

LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Also known as: LUMIGAN® RC

LUMIGAN® RC

Eligibility Criteria

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

You may qualify if:

• Open angle glaucoma or ocular hypertension
• Best corrected visual acuity of 20/100 or better in both eyes

You may not qualify if:

• Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
• Previous treatment with LUMIGAN® RC or DuoTrav®
• History of LASIK, LASEK, RK or PRK in the study eye(s)
• Active ocular inflammation

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost; Timolol; Duotrav

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

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: February 10, 2012
• First Posted: March 8, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

CA (1)