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OpenTrials
Completed

NCT Number: NCT00539526

Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Diego, 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 open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion criteria

  • Known contraindication to latanoprost, bimatoprost or travoprost
  • Uncontrolled systemic disease
  • Active ocular disease other than glaucoma or ocular hypertension
  • Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control

Treatment and study plan

bimatoprost 0.03%

Drug

bimatoprost 0.03%, 1 drop nightly for 3 months

Other names: Lumigan®

Travoprost 0.004%

Drug

travoprost 0.004% eye drops, 1 drop nightly for 3 months

Other names: Travatan® Z

latanoprost 0.005% eye drops

Drug

latanoprost 0.005%, 1 drop nightly for 3 months

Other names: Xalatan®

Primary outcomes

  1. Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3

    Time frame: Baseline, Month 3

    Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in Corneal Staining With Fluorescein at Month 3

    Time frame: Baseline, Month 3

    Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.

  2. Change From Baseline in Tear Break-Up Time (TBUT) at Month 3

    Time frame: Baseline, Month 3

    Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 4, 2007
Registry last updated
Apr 24, 2019

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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