Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief 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.

Official Title
-----------------
A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.01% ophthalmic solution
* Drug: bimatoprost 0.03% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost 0.01% Ophthalmic Solution<br>One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. | Drug: bimatoprost 0.01% ophthalmic solution<br>* One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.<br>* Other names: LUMIGAN 0.1 mg/ml;|
| Active Comparator: Bimatoprost 0.03% Ophthalmic Solution<br>One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. | Drug: bimatoprost 0.03% ophthalmic solution<br>* One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.<br>* Other names: LUMIGAN 0.3 mg/ml;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia | An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported. | 24 Months |