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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216943
• Other study ID #: 192024-049
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2010
• Last updated: July 16, 2013
• Start date: November 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).	Baseline, Week 12	No