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OpenTrials
Completed

NCT Number: NCT01525173

A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension

This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.

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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 4

Primary location

Deerfield Beach, Florida, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ocular hypertension or glaucoma in at least 1 eye
  • Visual acuity of 20/100 or better in both eyes

Exclusion criteria

  • Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
  • Intraocular or glaucoma surgery in the past 3 months

Treatment and study plan

0.1% brimonidine tartrate ophthalmic solution

Drug

1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.

Other names: ALPHAGAN® P

0.01% bimatoprost ophthalmic solution

Drug

1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.

Other names: LUMIGAN®

0.2% hypromellose lubricant eye drops

Drug

1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.

Other names: GenTeal ®

Latanoprost 0.005% Ophthalmic Solution

Drug

1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Primary outcomes

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

    Time frame: Baseline, Week 12

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2012
Registry last updated
Dec 4, 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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