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Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Sponsor
Glaukos Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03519386
Collaborator
(none)
1,000
Enrollment
1
Location
3
Arms
72.3
Anticipated Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Condition or Disease Intervention/Treatment Phase
  • Combination Product: G2TR intraocular implant containing travoprost
  • Drug: Sham surgery + active-comparator eye drops
 Phase 3

Detailed Description

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Actual Study Start Date :
May 22, 2018
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Implant Group 1

G2TR intraocular implant containing travoprost 78 mcg with high elution rate, plus postoperative placebo eye drops.

Combination Product: G2TR intraocular implant containing travoprost
Provided in Arm/Group descriptions.
Other Names:
  • Implant Group

    		•
    Experimental: Implant Group 2

    G2TR intraocular implant containing travoprost 78 mcg with low elution rate, plus postoperative placebo eye drops.

    Combination Product: G2TR intraocular implant containing travoprost
    Provided in Arm/Group descriptions.
    Other Names:
  • Implant Group

    		•
    Active Comparator: Control Group

    Sham surgery + active-comparator eye drops

    Drug: Sham surgery + active-comparator eye drops
    Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).
    Other Names:
  • Control Group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean IOP (Control Group vs. Each Implant Group) through 3 months postoperative [3 months]

      Difference in mean diurnal IOP, between each test group and the control group, for IOP measurements through the Month 3 follow-up visit.

    Secondary Outcome Measures

    1. Mean IOP (Control Group vs. Each Implant Group) through 12 months postoperative [12 months]

      Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with open-angle glaucoma or ocular hypertension.

    • C/D ratio ≤ 0.8

    • Zero to three preoperative ocular hypotensive medications

    Exclusion Criteria:

    • Active corneal inflammation or edema.

    • Retinal disorders not associated with glaucoma.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vance Thompson Vision Sioux Falls South Dakota United States 57108

    Sponsors and Collaborators

    • Glaukos Corporation

    Investigators

    • Study Chair: Kerry Stephens, O.D., Glaukos Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Glaukos Corporation
    ClinicalTrials.gov Identifier:
    NCT03519386
    Other Study ID Numbers:
    • GC-010
    First Posted:
    May 9, 2018
    Last Update Posted:
    Apr 30, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Ocular Hypertension
    Glaucoma, Open-Angle
    Travoprost
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Apr 30, 2021