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NCT03519386 · ClinicalTrials.gov registry record · Phase 3
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
A Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle, sponsored by Glaukos Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 590
- Enrollment target
- 1
- Study location
NCT03519386: Completed Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle, sponsored by Glaukos Corporation.
NCT03519386 is a Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle that has completed, run by Glaukos Corporation. The registered enrollment target is 590 participants, above the 267-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (121% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03519386, a Phase 3 study of Ocular Hypertension and Glaucoma Open-Angle, has completed, sponsored by Glaukos Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 590 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.
Conditions Studied
Interventions
- COMBINATION_PRODUCT G2-TR intraocular implant containing travoprost
- DRUG Sham surgery + active-comparator eye drops
Study Locations (1)
South Dakota
- Vance Thompson Vision - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 590 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 3 |
What the finished NCT03519386 record still lists
NCT03519386 is an interventional study that assigns participants to a tested intervention. The registered 590 participants enrollment target is mid-sized for trials with a published cap, above the 267-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (121% higher).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 2 interventions - of which G2-TR intraocular implant containing travoprost is the first listed.
NCT03519386 reports a single indexed study location in South Dakota.
Frequently Asked Questions
What is clinical trial NCT03519386 about?
NCT03519386 is a clinical study titled "Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%". 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)...
What is the current status of trial NCT03519386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 590 participants. The study started on 2018-07-26. Estimated completion is 2024-04-02.
What conditions does trial NCT03519386 study?
This clinical trial studies the following conditions: Ocular Hypertension, Glaucoma Open-Angle.
What interventions are being tested in trial NCT03519386?
The interventions under investigation include: G2-TR intraocular implant containing travoprost (COMBINATION_PRODUCT), Sham surgery + active-comparator eye drops (DRUG).
Who is sponsoring clinical trial NCT03519386?
This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03519386 being conducted?
This trial has 1 study location across South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ocular Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03519386's enrollment target sits among peer trials
590 8th of 54 higher than 47 of 54 other Ocular Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ocular Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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