Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: bimatoprost 0.01% (Drug); travoprost 0.004% (Drug); timolol 0.5% (Drug); hypromellose 0.3% (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0. 01%) alone compared
to TRAVATAN Z® (travoprost 0. 004%) and TIMOLOL GFS, 0. 5% (timolol 0. 5% ophthalmic gel
forming solution) in patients who require IOP lowering therapy.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Intraocular Pressure (IOP) in the Study Eye
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ocular hypertension or glaucoma that requires treatment with medication
- Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes
Exclusion Criteria:
- History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
- History of any intraocular surgery or glaucoma laser surgery in the study eye(s)
within 3 months
- Use of topical, periorbital, intravitreal or systemic steroid within 3 months or
expected use during the course of study
Locations and Contacts
Racine, Wisconsin, United States
Additional Information
Starting date: April 2014
Last updated: December 9, 2014
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