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Completed

NCT Number: NCT01177098

Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

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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

Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has ocular hypertension or glaucoma in both eyes
  • Requires IOP-lowering therapy in each eye

Exclusion criteria

  • Active or recurrent eye disease that would interfere with interpretation of study data in either eye
  • History of any eye surgery or laser in either eye within 6 months
  • Required chronic use of other eye medications during the study
  • Anticipated wearing of contact lenses during the study.
  • Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Treatment and study plan

bimatoprost /timolol formulation A fixed combination ophthalmic solution

Drug

One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

bimatoprost/timolol fixed combination ophthalmic solution

Drug

One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Other names: GANFORT®

Primary outcomes

  1. Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

    Time frame: Baseline, Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

  2. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2

    Time frame: Week 2

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.

  3. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6

    Time frame: Week 6

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.

  4. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12

    Time frame: Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.

Secondary outcomes

  1. Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12

    Time frame: Baseline, Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

  2. Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12

    Time frame: Baseline, Week 12

    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2010
Registry last updated
Mar 29, 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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