Phase 3 Completed N=126 Treatment

Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

Glaucoma · Hypertension

Source: ClinicalTrials.gov NCT01216943 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcomePrimary: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye — 22.35; -3.98 Millimeters of Mercury (mmHg)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye	22.35; -3.98	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01216943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.