Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

NCT02754596 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GC-009
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma Open-angle

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Other Outcomes (1)

• Severe Adverse Events

  Post-op through Month 36

Study Arms (3)

Travoprost Intraocular Implant, high elution

EXPERIMENTAL

This implant will be surgically implanted and elute travoprost, a prostaglandin.

Drug: Travoprost Intraocular Implant, high elution

Travoprost Intraocular Implant, low elution

EXPERIMENTAL

This implant will be surgically implanted and elute travoprost, a prostaglandin.

Drug: Travoprost Intraocular Implant, low elution

Timolol Maleate Ophthalmic Solution, 0.5%

ACTIVE COMPARATOR

Timolol, a beta blocker, will be dosed twice daily

Drug: Timolol Maleate Ophthalmic Solution, 0.5%

Interventions

Travoprost Intraocular Implant, high elution DRUG

Surgical implant placed within the eye to elute travoprost.

Travoprost Intraocular Implant, high elution

Travoprost Intraocular Implant, low elution DRUG

Surgical implant placed within the eye to elute travoprost

Travoprost Intraocular Implant, low elution

Timolol Maleate Ophthalmic Solution, 0.5% DRUG

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

Timolol Maleate Ophthalmic Solution, 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open angle glaucoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

John Berdahl, MD

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (1)

• Berdahl JP, Sarkisian SR Jr, Ang RE, Doan LV, Kothe AC, Usner DW, Katz LJ, Navratil T; Travoprost Intraocular Implant Study Group. Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension. Drugs. 2024 Jan;84(1):83-97. doi: 10.1007/s40265-023-01973-7. Epub 2023 Dec 7.

  PMID: 38060092 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Study Manager
• Organization: Glaukos

ldoan@glaukos.com

949-481-8076

Study Officials

• Kerry Stephens, O.D.

  Glaukos Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 28, 2016
• Study Start: March 29, 2016
• Primary Completion: August 1, 2017
• Study Completion: July 21, 2020
• Last Updated: September 26, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)