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

Phase 1

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: VS101 Insert Dose A; Drug: VS101 Insert Dose B; Drug: VS101 Insert Dose C; Drug: Latanoprost 0.005% eye drops

• Registration Number: NCT02129673
• Lead Sponsor: ViSci Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-02
• Primary Completion: 2017-05
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Age > 18
• Open angle glaucoma or Ocular Hypertension

Exclusion Criteria

• uncontrolled medical conditions
• wearing of contact lenses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VS101 Insert Dose A	VS101 Insert Dose A	VS101 Insert Dose A placed under the conjunctiva
VS101 Insert Dose B	VS101 Insert Dose B	VS101 Insert Dose B placed under the conjunctiva
VS101 Insert Dose C	VS101 Insert Dose C	VS101 Insert Dose C placed under the conjunctiva
Latanoprost 0.005% eye drops	Latanoprost 0.005% eye drops	Latanoprost 0.005% eye drops administered once daily on the eye

Primary Outcome Measures

Name	Time	Method
Intra-ocular pressure	12 weeks

Secondary Outcome Measures

Name	Time	Method
Intra-ocular pressure	4 weeks

Trial Locations

Locations (1)

Speciality Eyecare Centre; 🇺🇸 Bellevue, Washington, United States