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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

NCT ID: NCT02129673

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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VS101 Insert Dose A

VS101 Insert Dose A placed under the conjunctiva

Group Type EXPERIMENTAL

VS101 Insert Dose A

Intervention Type DRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose B

VS101 Insert Dose B placed under the conjunctiva

Group Type EXPERIMENTAL

VS101 Insert Dose B

Intervention Type DRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose C

VS101 Insert Dose C placed under the conjunctiva

Group Type EXPERIMENTAL

VS101 Insert Dose C

Intervention Type DRUG

Sustained release of latanoprost into the eye

Latanoprost 0.005% eye drops

Latanoprost 0.005% eye drops administered once daily on the eye

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% eye drops

Intervention Type DRUG

Latanoprost 0.005% eye drops administered once daily on the eye

Interventions

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VS101 Insert Dose A

Sustained release of latanoprost into the eye

Intervention Type DRUG

VS101 Insert Dose B

Sustained release of latanoprost into the eye

Intervention Type DRUG

VS101 Insert Dose C

Sustained release of latanoprost into the eye

Intervention Type DRUG

Latanoprost 0.005% eye drops

Latanoprost 0.005% eye drops administered once daily on the eye

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Open angle glaucoma or Ocular Hypertension

Exclusion Criteria

* uncontrolled medical conditions
* wearing of contact lenses
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViSci Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Speciality Eyecare Centre

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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VS101-CS201

Identifier Type: -

Identifier Source: org_study_id

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