Safety and Efficacy of a Drug Delivery System in Glaucoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01016691
• Date of registration: 18/11/2009
• Primary sponsor: Vistakon Pharmaceuticals
• Public title: Safety and Efficacy of a Drug Delivery System in Glaucoma
• Date of first enrolment: October 2009
• Target sample size: 47
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01016691
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ocular Hypertension

Open-angle Glaucoma

Intervention(s)

Drug: bimatoprost 0.03%

Drug: High Dose Drug Device

Drug: Low Dose Drug Device

Drug: Placebo Device

Primary Outcome(s)

Mean Change in Intraocular Pressure at Day 1 [Time Frame: Baseline to Day 1]

Secondary Outcome(s)

Mean Change in Intraocular Pressure at Day 2 [Time Frame: Baseline to Day 2]

Mean Change in Intraocular Pressure at Day 3 [Time Frame: Baseline to Day 3]

Mean Change in Intraocular Pressure at Day 4 [Time Frame: Baseline to Day 4]

Mean Change in Intraocular Pressure at Day 5 [Time Frame: Day 4 to Day 5]

Secondary ID(s)

CR-1649

Source(s) of Monetary Support

Please refer to primary and secondary sponsors