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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01547598
First received: February 10, 2012
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

This 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.


Condition Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
Drug: travoprost ophthalmic solution 0.004%
Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
Drug: Bimatoprost ophthalmic solution 0.01%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Diurnal Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients with ≥15% Reduction in IOP from Baseline [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients With Diurnal IOP Less Than 18 mmHg [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LUMIGAN® RC
Travatan® Z (travoprost ophthalmic solution 0.004%) will be administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) will be administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Drug: travoprost ophthalmic solution 0.004%
Travatan® Z (travoprost ophthalmic solution 0.004%) will be administered as 1 drop in the affected eye(s) once a day for 4 weeks.
Other Name: Travatan® Z
Drug: Bimatoprost ophthalmic solution 0.01%
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) will be administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Other Name: LUMIGAN® RC
Active Comparator: DuoTrav®
Travatan® Z (travoprost ophthalmic solution 0.004%) will be 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) will be administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Drug: travoprost ophthalmic solution 0.004%
Travatan® Z (travoprost ophthalmic solution 0.004%) will be administered as 1 drop in the affected eye(s) once a day for 4 weeks.
Other Name: Travatan® Z
Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) will be administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Other Name: DuoTrav®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547598

Locations
Canada, Ontario
Vancouver, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01547598     History of Changes
Other Study ID Numbers: GMA-LUM-11-020
Study First Received: February 10, 2012
Last Updated: September 4, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Travoprost
Bimatoprost
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 17, 2014