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Completed

NCT Number: NCT01216943

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Coimbatore, Tamil Nadu, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye

    Time frame: Baseline, Week 12

    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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2010
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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