NCT02129673CompletedPhase 1
A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension
ViSci Ltd.1 site in 1 country77 target enrollmentStarted: May 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Intra-ocular pressure
Study Overview
Brief Summary
Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18
- •Open angle glaucoma or Ocular Hypertension
Exclusion Criteria
- •uncontrolled medical conditions
- •wearing of contact lenses
Arms & Interventions
VS101 Insert Dose A
Experimental
VS101 Insert Dose A placed under the conjunctiva
Intervention: VS101 Insert Dose A (Drug)
VS101 Insert Dose B
Experimental
VS101 Insert Dose B placed under the conjunctiva
Intervention: VS101 Insert Dose B (Drug)
VS101 Insert Dose C
Experimental
VS101 Insert Dose C placed under the conjunctiva
Intervention: VS101 Insert Dose C (Drug)
Latanoprost 0.005% eye drops
Active Comparator
Latanoprost 0.005% eye drops administered once daily on the eye
Intervention: Latanoprost 0.005% eye drops (Drug)
Outcomes
Primary Outcomes
Intra-ocular pressure
Time Frame: 12 weeks
Secondary Outcomes
- Intra-ocular pressure(4 weeks)
Investigators
Study Sites (1)
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