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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 is a Phase 2 study that has completed, run by Inotek Pharmaceuticals Corporation. The registered enrollment target is 201 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02829996
The ClinicalTrials.gov registry entry for NCT02829996 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inotek Pharmaceuticals Corporation, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which trabodenoson 6.0% / latanoprost 0.005% QD is the first listed.
NCT02829996 reports 0 study locations.
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.
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