Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539526
• Other study ID #: MA-LUM-07-003
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Bimatoprost 0.03%
bimatoprost 0.03%, 1 drop nightly for 3 months
• travoprost 0.004%
travoprost 0.004% eye drops, 1 drop nightly for 3 months
• latanoprost 0.005% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010 Jun;26(3):287-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Conjunctival Hyperemia Scores at 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.	Baseline, Month 3
Secondary	Change From Baseline in Corneal Staining With Fluorescein at 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.	Baseline, Month 3
Secondary	Change From Baseline in Tear Break-Up Time (TBUT) at 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.	Baseline, Month 3