Back to resultsStudy Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
Primary Purpose
Glaucoma Open-angle
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Travoprost Intraocular Implant, high elution
Travoprost Intraocular Implant, low elution
Timolol Maleate Ophthalmic Solution, 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma Open-angle
Eligibility 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.
Sites / Locations
- John Berdahl, MD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Travoprost Intraocular Implant, high elution
Travoprost Intraocular Implant, low elution
Timolol Maleate Ophthalmic Solution, 0.5%
Arm Description
This implant will be surgically implanted and elute travoprost, a prostaglandin.
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Timolol, a beta blocker, will be dosed twice daily
Outcomes
Primary Outcome Measures
IOP (mmHg) Change From Baseline at Week 12
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02754596
Brief Title
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
July 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Open-angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost Intraocular Implant, high elution
Arm Type
Experimental
Arm Description
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Arm Title
Travoprost Intraocular Implant, low elution
Arm Type
Experimental
Arm Description
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Arm Title
Timolol Maleate Ophthalmic Solution, 0.5%
Arm Type
Active Comparator
Arm Description
Timolol, a beta blocker, will be dosed twice daily
Intervention Type
Drug
Intervention Name(s)
Travoprost Intraocular Implant, high elution
Intervention Description
Surgical implant placed within the eye to elute travoprost.
Intervention Type
Drug
Intervention Name(s)
Travoprost Intraocular Implant, low elution
Intervention Description
Surgical implant placed within the eye to elute travoprost
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate Ophthalmic Solution, 0.5%
Intervention Description
Instillation of one drop of timolol in the study eye twice daily
Primary Outcome Measure Information:
Title
IOP (mmHg) Change From Baseline at Week 12
Description
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Severe Adverse Events
Description
The number and percent of subjects with severe adverse events in the study eye
Time Frame
Post-op through Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Stephens, O.D.
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
John Berdahl, MD
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated during and/or analyzed during the current study are not publicly available at this time due to ongoing U.S. Food and Drug Administration review of a New Drug Application for the travoprost intraocular implant.
Learn more about this trial
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
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