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

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ClinicalTrials.gov Identifier: NCT03519386
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

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
Glaucoma, Open-Angle Ocular Hypertension 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 Type : Interventional  (Clinical Trial)
Estimated 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%
Estimated Study Start Date : May 31, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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 Name: 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 Name: 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 Name: Control Group




Primary Outcome Measures :
  1. Mean IOP (Control Group vs. Each Implant Group) through 3 months postoperative [ Time Frame: 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 [ Time Frame: 12 months ]
    Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit.



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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:

  • 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.

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): NCT03519386


Contacts
Contact: Nicholas Tarantino, O.D. 949-481-8072 ntarantino@glaukos.com
Contact: Dana M Hornbeak, M.D., M.P.H. 949-367-9600 ext 1296 dana.hornbeak@gmail.com

Locations
United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: John P Berdahl, M.D.    605-361-3937    john.berdahl@vancethompsonvision.com   
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Chair: Nicholas Tarantino, O.D. Glaukos Corporation

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT03519386     History of Changes
Other Study ID Numbers: GC-010
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Ocular Hypertension
Glaucoma, Open-Angle
Eye Diseases
Glaucoma
Ophthalmic Solutions
Timolol
Travoprost
Maleic acid
Pharmaceutical Solutions
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