Status:
COMPLETED
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Allergan
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and lata...
Eligibility Criteria
Inclusion
- Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
- Best corrected visual acuity score of 20/100 or better in both eyes
- Females on birth control pills must be on same type of pill and dose for at least 3 month
Exclusion
- Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
- History of or active ocular infection/inflammation (eg, uveitis)
- Punctal plug use
- Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
- Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
- History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
- Planned contact lens wear during study
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT01253902
Start Date
December 1 2010
End Date
October 1 2011
Last Update
November 7 2012
Active Locations (2)
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1
Rogers, Arkansas, United States
2
Calgary, Alberta, Canada