Clinical Trial: Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: 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.


Original Primary Outcome: Hyperemia

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome:

Information By: Allergan

Dates:
Date Received: October 2, 2007
Date Started: September 2007
Date Completion:
Last Updated: September 22, 2011
Last Verified: September 2011