Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
Summary
This study will investigate the safety and efficacy of Triple Combination Therapy
(bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients
with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on
brimonidine/timolol ophthalmic solution.
Clinical Details
Official title: A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Glaucoma and/or ocular hypertension in both eyes
- Requires IOP-lowering treatment in both eyes
Exclusion Criteria:
- Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis,
ocular infections or severe dry eye)
- Current or anticipated use of ocular medications other than study medications, except
for intermittent use of artificial tears
- Use of oral, injectable or topical corticosteroids within 21 days
- Iridectomy or laser peripheral iridotomy in the study eye within 3 months
- Uncomplicated cataract surgery in the study eye within 6 months
- Incisional glaucoma surgery in the study eye within 12 months
Locations and Contacts
Coimbatore, Tamil Nadu, India
Additional Information
Starting date: November 2010
Last updated: July 16, 2013
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