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Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

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ClinicalTrials.gov Identifier: NCT02754596
Recruitment Status : Active, not recruiting
First Posted : April 28, 2016
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

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

Condition or disease Intervention/treatment Phase
Glaucoma Open-angle Drug: Travoprost Intraocular Implant, high elution Drug: Travoprost Intraocular Implant, low elution Drug: Timolol Maleate Ophthalmic Solution, 0.5% Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP, 0.5%
Study Start Date : March 2016
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Travoprost Intraocular Implant, high elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Drug: Travoprost Intraocular Implant, high elution
Surgical implant placed within the eye to elute travoprost.

Experimental: Travoprost Intraocular Implant, low elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Drug: Travoprost Intraocular Implant, low elution
Surgical implant placed within the eye to elute travoprost

Active Comparator: Timolol Maleate Ophthalmic Solution, 0.5%
Timolol, a beta blocker, will be dosed twice daily
Drug: Timolol Maleate Ophthalmic Solution, 0.5%
Instillation of one drop of timolol in the study eye twice daily




Primary Outcome Measures :
  1. Intraocular pressure (IOP) measured in mm Hg [ Time Frame: 12 weeks ]
    IOP reduction--mean diurnal values from 8am, 10 am, and 4 pm


Other Outcome Measures:
  1. Adverse events [ Time Frame: Post-op through 12 weeks ]
    The number and percent of adverse events will be reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754596


Locations
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United States, South Dakota
John Berdahl, MD
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Glaukos Corporation
Investigators
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Study Chair: Kerry Stephens, O.D. Glaukos Corporation

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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT02754596     History of Changes
Other Study ID Numbers: GC-009
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Travoprost
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors