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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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