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OpenTrials
Completed

NCT Number: NCT02129673

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

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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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Speciality Eyecare Centre

Bellevue, Washington, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18
  • Open angle glaucoma or Ocular Hypertension

Exclusion criteria

  • uncontrolled medical conditions
  • wearing of contact lenses

Treatment and study plan

VS101 Insert Dose A

Drug

Sustained release of latanoprost into the eye

VS101 Insert Dose B

Drug

Sustained release of latanoprost into the eye

VS101 Insert Dose C

Drug

Sustained release of latanoprost into the eye

latanoprost 0.005% eye drops

Drug

Latanoprost 0.005% eye drops administered once daily on the eye

Primary outcomes

  1. Intra-ocular pressure

    Time frame: 12 weeks

Secondary outcomes

  1. Intra-ocular pressure

    Time frame: Week 8

  2. Intra-ocular pressure

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

ViSci Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 2, 2014
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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