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

ViSci Ltd.77 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

VS101 Insert Dose ADRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose BDRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose CDRUG

Sustained release of latanoprost into the eye

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 * Open angle glaucoma or Ocular Hypertension Exclusion Criteria: * uncontrolled medical conditions * wearing of contact lenses

Locations (1)

Speciality Eyecare Centre

Bellevue, Washington, United States

Outcomes

Primary Outcomes

Intra-ocular pressure

Time frame: 12 weeks

Secondary Outcomes

Intra-ocular pressure

Time frame: Week 8

Intra-ocular pressure

Time frame: 4 weeks

Data from ClinicalTrials.gov

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