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NCT02829996 · ClinicalTrials.gov registry record · Phase 2
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG
A Phase 2 study, sponsored by Inotek Pharmaceuticals Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 201
- Enrollment target
NCT02829996: Completed Phase 2 study, sponsored by Inotek Pharmaceuticals Corporation.
NCT02829996 is a Phase 2 study that has completed, run by Inotek Pharmaceuticals Corporation. The registered enrollment target is 201 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02829996, a Phase 2 study, has completed, sponsored by Inotek Pharmaceuticals Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 201 participants
- Enrollment target
Study Summary
Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in 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 (if washout is needed), including their routine glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active drug product. During the Treatment Period, study drug (Active and Placebo) eye drop applications will occur twice daily, in the morning and in the evening. The Treatment Period will be 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 overall benefit/risk profile of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.
Primary Outcome
Daily change from diurnal baseline in IOP
Interventions
- DRUG trabodenoson 6.0% / latanoprost 0.005% QD
- DRUG trabodenoson 3.0% / latanoprost 0.005% QD
- DRUG trabodenoson 6.0% / latanoprost 0.0025% QD
- DRUG latanoprost 0.005% QD
- DRUG latanoprost 0.0025% QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2016-08-19 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 2 |
What the finished NCT02829996 record still lists
NCT02829996 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 5 interventions - of which trabodenoson 6.0% / latanoprost 0.005% QD is the first listed.
NCT02829996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02829996 about?
NCT02829996 is a clinical study titled "Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG". Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria follo...
What is the current status of trial NCT02829996?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2016-08-19. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT02829996?
The interventions under investigation include: trabodenoson 6.0% / latanoprost 0.005% QD (DRUG), trabodenoson 3.0% / latanoprost 0.005% QD (DRUG), trabodenoson 6.0% / latanoprost 0.0025% QD (DRUG), latanoprost 0.005% QD (DRUG), latanoprost 0.0025% QD (DRUG).
Who is sponsoring clinical trial NCT02829996?
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 NCT02829996's enrollment target sits among peer trials
201 302nd of 2000 higher than 1,697 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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