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OpenTrials
Completed

NCT Number: NCT01863953

A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of ocular hypertension or glaucoma
  • Requires intraocular pressure (IOP)-lowering therapy

Exclusion criteria

  • Cataract surgery in one eye
  • Ocular laser or intraocular surgery within 6 months
  • Refractive surgery in either eye
  • Anticipated use of contact lenses during the study
  • Expected use of artificial tears during the study

Treatment and study plan

Fixed-Combination Bimatoprost/Brimonidine

Drug

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Bimatoprost Ophthalmic Solution 0.01%

Drug

One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.

Other names: LUMIGAN

Vehicle Ophthalmic Solution

Drug

One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Brimonidine Tartrate Ophthalmic Solution 0.2%

Drug

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Other names: ALPHAGAN

Primary outcomes

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

    Time frame: Baseline, Day 42

    IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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).

Secondary outcomes

  1. Change From Baseline in Average Eye Mean Diurnal IOP

    Time frame: Baseline, Day 14, Day 28

    IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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).

  2. Average Eye Mean Diurnal IOP

    Time frame: Day 14, Day 28, Day 42

    IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 29, 2013
Registry last updated
Jan 26, 2015

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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