Back to resultsEvaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost 0.03%
travoprost 0.004%
latanoprost 0.005% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
bimatoprost 0.03%
travoprost 0.004%
latanoprost 0.005%
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00539526
Brief Title
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
bimatoprost 0.03%
Arm Title
2
Arm Type
Active Comparator
Arm Description
travoprost 0.004%
Arm Title
3
Arm Type
Active Comparator
Arm Description
latanoprost 0.005%
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03%
Other Intervention Name(s)
Lumigan®
Intervention Description
bimatoprost 0.03%, 1 drop nightly for 3 months
Intervention Type
Drug
Intervention Name(s)
travoprost 0.004%
Other Intervention Name(s)
Travatan® Z
Intervention Description
travoprost 0.004% eye drops, 1 drop nightly for 3 months
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% eye drops
Other Intervention Name(s)
Xalatan®
Intervention Description
latanoprost 0.005%, 1 drop nightly for 3 months
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Description
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.
Time Frame
Baseline, Month 3
Secondary Outcome Measure Information:
Title
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Description
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.
Time Frame
Baseline, Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20578283
Citation
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. doi: 10.1089/jop.2009.0134.
Results Reference
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Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
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