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NCT02565173 · ClinicalTrials.gov registry record · Phase 3
Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
A Phase 3 study, sponsored by Inotek Pharmaceuticals Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 303
- Enrollment target
NCT02565173: Completed Phase 3 study, sponsored by Inotek Pharmaceuticals Corporation.
NCT02565173 is a Phase 3 study that has completed, run by Inotek Pharmaceuticals Corporation. The registered enrollment target is 303 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02565173, a Phase 3 study, has completed, sponsored by Inotek Pharmaceuticals Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 303 participants
- Enrollment target
Study Summary
Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.
Interventions
- DRUG trabodenoson 4.5% BID
- DRUG trabodenoson 6.0% QD
- DRUG trabodenoson 3.0% QD
- DRUG timolol 0.5% BID
- DRUG placebo BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02565173 record still lists
NCT02565173 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 5 interventions - of which trabodenoson 4.5% BID is the first listed.
NCT02565173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02565173 about?
NCT02565173 is a clinical study titled "Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma". Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subje...
What is the current status of trial NCT02565173?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2015-09. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02565173?
The interventions under investigation include: trabodenoson 4.5% BID (DRUG), trabodenoson 6.0% QD (DRUG), trabodenoson 3.0% QD (DRUG), timolol 0.5% BID (DRUG), placebo BID (DRUG).
Who is sponsoring clinical trial NCT02565173?
This trial is sponsored by Inotek Pharmaceuticals Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02565173's enrollment target sits among peer trials
303 1119th of 2000 higher than 882 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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