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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01216943
First received: October 6, 2010
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 126
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple Combination Therapy
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
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216943

Locations
India
Coimbatore, Tamil Nadu, India
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01216943     History of Changes
Other Study ID Numbers: 192024-049
Study First Received: October 6, 2010
Results First Received: July 16, 2013
Last Updated: July 16, 2013
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on April 17, 2014