Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
This study is currently recruiting participants.
Verified March 2013 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01547598
First received: February 10, 2012
Last updated: March 13, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 128 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 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
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| Canada, Ontario | |
| Recruiting | |
| 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: | March 13, 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 May 19, 2013