Overview

This trial is active, not recruiting.

Conditions glaucoma, ocular hypertension
Treatments bimatoprost 0.01% ophthalmic solution, bimatoprost 0.03% ophthalmic solution
Phase phase 4
Sponsor Allergan
Start date April 2011
End date December 2016
Trial size 807 participants
Trial identifier NCT01298700, 192024-054

Summary

This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
bimatoprost 0.01% ophthalmic solution LUMIGAN® 0.01%
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
(Active Comparator)
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
bimatoprost 0.03% ophthalmic solution LUMIGAN® 0.03%
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

Primary Outcomes

Measure
Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events
time frame: Month 24

Secondary Outcomes

Measure
Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia"
time frame: Month 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Ocular hypertension or glaucoma in each eye - Requires intraocular pressure (IOP)-lowering therapy in both eyes - Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: - Ocular seasonal allergies within 2 years - Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed) - Ocular surgery or laser within 3 months - Anticipated wearing of contact lenses during the study

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Allergan.