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Completed

NCT Number: NCT02754596

Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

John Berdahl, MD

Sioux Falls, South Dakota, 57108, United States

About this study

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Open angle glaucoma

Exclusion criteria

  • Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
  • Functionally significant visual field loss, including severe nerve fiber bundle defects.
  • Prior glaucoma surgery.
  • Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
  • Other ocular status conditions, etc.

Treatment and study plan

Travoprost Intraocular Implant, high elution

Drug

Surgical implant placed within the eye to elute travoprost.

Travoprost Intraocular Implant, low elution

Drug

Surgical implant placed within the eye to elute travoprost

Timolol Maleate Ophthalmic Solution, 0.5%

Drug

Instillation of one drop of timolol in the study eye twice daily

Primary outcomes

  1. IOP (mmHg) Change From Baseline at Week 12

    Time frame: 12 weeks

    Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.

Other outcomes

  1. Severe Adverse Events

    Time frame: Post-op through Month 36

    The number and percent of subjects with severe adverse events in the study eye

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Apr 28, 2016
Registry last updated
Sep 26, 2023

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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