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NCT02129673 Clinical 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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02129673
Other study ID # VS101-CS201
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 30, 2014
Last updated March 13, 2018
Start date May 2014
Est. completion date August 2017

Study information
Verified date October 2017
Source ViSci Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date August 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Age > 18

- Open angle glaucoma or Ocular Hypertension

Exclusion Criteria:

- uncontrolled medical conditions

- wearing of contact lenses

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VS101 Insert Dose A
Sustained release of latanoprost into the eye
• VS101 Insert Dose B
Sustained release of latanoprost into the eye
• VS101 Insert Dose C
Sustained release of latanoprost into the eye
• Latanoprost 0.005% eye drops
Latanoprost 0.005% eye drops administered once daily on the eye

Locations
Country Name City State
United States Speciality Eyecare Centre Bellevue Washington

Sponsors (1)
Lead Sponsor Collaborator
ViSci Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intra-ocular pressure 12 weeks
Secondary Intra-ocular pressure Week 8
Secondary Intra-ocular pressure 4 weeks
See also
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