Back to resultsA Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VS101 Insert Dose A
VS101 Insert Dose B
VS101 Insert Dose C
Latanoprost 0.005% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Glaucoma, Intra-ocular pressure, Slow Release, Controlled release
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Open angle glaucoma or Ocular Hypertension
Exclusion Criteria:
- uncontrolled medical conditions
- wearing of contact lenses
Sites / Locations
- Speciality Eyecare Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
VS101 Insert Dose A
VS101 Insert Dose B
VS101 Insert Dose C
Latanoprost 0.005% eye drops
Arm Description
VS101 Insert Dose A placed under the conjunctiva
VS101 Insert Dose B placed under the conjunctiva
VS101 Insert Dose C placed under the conjunctiva
Latanoprost 0.005% eye drops administered once daily on the eye
Outcomes
Primary Outcome Measures
Intra-ocular pressure
Secondary Outcome Measures
Intra-ocular pressure
Intra-ocular pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02129673
Brief Title
A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViSci Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Intra-ocular pressure, Slow Release, Controlled release
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VS101 Insert Dose A
Arm Type
Experimental
Arm Description
VS101 Insert Dose A placed under the conjunctiva
Arm Title
VS101 Insert Dose B
Arm Type
Experimental
Arm Description
VS101 Insert Dose B placed under the conjunctiva
Arm Title
VS101 Insert Dose C
Arm Type
Experimental
Arm Description
VS101 Insert Dose C placed under the conjunctiva
Arm Title
Latanoprost 0.005% eye drops
Arm Type
Active Comparator
Arm Description
Latanoprost 0.005% eye drops administered once daily on the eye
Intervention Type
Drug
Intervention Name(s)
VS101 Insert Dose A
Intervention Description
Sustained release of latanoprost into the eye
Intervention Type
Drug
Intervention Name(s)
VS101 Insert Dose B
Intervention Description
Sustained release of latanoprost into the eye
Intervention Type
Drug
Intervention Name(s)
VS101 Insert Dose C
Intervention Description
Sustained release of latanoprost into the eye
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005% eye drops
Intervention Description
Latanoprost 0.005% eye drops administered once daily on the eye
Primary Outcome Measure Information:
Title
Intra-ocular pressure
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intra-ocular pressure
Time Frame
Week 8
Title
Intra-ocular pressure
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
Open angle glaucoma or Ocular Hypertension
Exclusion Criteria:
uncontrolled medical conditions
wearing of contact lenses
Facility Information:
Facility Name
Speciality Eyecare Centre
City
Bellevue
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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