Safety and Efficacy of a Drug Delivery System in Glaucoma
Overview
- Phase
- Phase 2
- Intervention
- High Dose Drug Device
- Conditions
- Open-angle Glaucoma
- Sponsor
- Vistakon Pharmaceuticals
- Enrollment
- 47
- Primary Endpoint
- Mean Change in Intraocular Pressure at Day 1
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Man or woman 21 years of age or greater
- •Open angle glaucoma or ocular hypertension
- •Corrected visual acuity in each eye of 20/200 or better
Exclusion Criteria
- •Previous glaucoma intraocular surgery or refractive surgery
- •Planned contact lens use during the study
- •Clinically significant ocular or systemic disease that might interfere with the study
- •Use of chronic corticosteroids by any route
Arms & Interventions
High Dose Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention: High Dose Drug Device
High Dose Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention: bimatoprost 0.03%
Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention: Low Dose Drug Device
Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention: bimatoprost 0.03%
Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention: Placebo Device
Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention: bimatoprost 0.03%
Outcomes
Primary Outcomes
Mean Change in Intraocular Pressure at Day 1
Time Frame: Baseline to Day 1
Secondary Outcomes
- Mean Change in Intraocular Pressure at Day 3(Baseline to Day 3)
- Mean Change in Intraocular Pressure at Day 2(Baseline to Day 2)
- Mean Change in Intraocular Pressure at Day 4(Baseline to Day 4)
- Mean Change in Intraocular Pressure at Day 5(Day 4 to Day 5)