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

NCT01216943 | Completed Phase 3 Results

• 1 other identifier: 192024-049
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Triple Combination Therapy

EXPERIMENTAL

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

Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution

Interventions

bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution DRUG

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

Triple Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glaucoma and/or ocular hypertension in both eyes
• Requires IOP-lowering treatment in both eyes

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Coimbatore, Tamil Nadu, India

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 19, 2013
• Results First Posted: September 19, 2013

Record last verified: 2013-07

Locations

IN (1)