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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Brimonidine
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014