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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 is a Phase 3 study that has completed, run by Inotek Pharmaceuticals Corporation. The registered enrollment target is 303 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02565173
The ClinicalTrials.gov registry entry for NCT02565173 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 303 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 4.5% BID is the first listed.
NCT02565173 reports 0 study locations.
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.
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