Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Information source: Allergan
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Hypertension; Primary Open-Angle Glaucoma
Intervention: Part 1: AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03% (Drug); Part 1: AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03% (Drug); Part 1: AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03% (Drug); Part 1: AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03% (Drug); Part 1: AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03% (Drug); Part 1: AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03% (Drug); Part 2: AGN-210961 Formulation to be selected from part 1 (Drug); Part 2: bimatoprost ophthalmic solution 0.03% (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
Summary
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of
AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0. 03% in
the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a
formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost
ophthalmic solution 0. 03% for 4 weeks.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Intraocular Pressure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ocular hypertension or primary open-angle glaucoma in each eye
Exclusion Criteria:
- Any active ocular disease
- Anticipated wearing of contact lenses during study
- Anticipated use of artificial tears during study
- Contraindication to pupil dilatation
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Newport Beach, California, United States; Recruiting
Additional Information
Starting date: August 2010
Last updated: September 8, 2010
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