Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
1 other identifier
interventional
106
1 country
1
Brief Summary
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 2, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
October 31, 2011
CompletedApril 24, 2019
April 1, 2019
10 months
October 2, 2007
September 22, 2011
April 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Baseline, Month 3
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Baseline, Month 3
Study Arms (3)
1
EXPERIMENTALbimatoprost 0.03%
2
ACTIVE COMPARATORtravoprost 0.004%
3
ACTIVE COMPARATORlatanoprost 0.005%
Interventions
travoprost 0.004% eye drops, 1 drop nightly for 3 months
latanoprost 0.005%, 1 drop nightly for 3 months
Eligibility Criteria
You may qualify if:
- Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
San Diego, California, United States
Related 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. doi: 10.1089/jop.2009.0134.
PMID: 20578283BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Medical Affairs
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2007
First Posted
October 4, 2007
Study Start
September 1, 2007
Primary Completion
July 1, 2008
Study Completion
September 1, 2008
Last Updated
April 24, 2019
Results First Posted
October 31, 2011
Record last verified: 2019-04