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NCT03131167 · ClinicalTrials.gov registry record · Phase 1
Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma
A Phase 1 study of Ocular Hypertension and Primary Open Angle Glaucoma (POAG), sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT03131167: Completed Phase 1 study of Ocular Hypertension and Primary Open Angle Glaucoma (POAG), sponsored by Shire.
NCT03131167 is a Phase 1 study of Ocular Hypertension and Primary Open Angle Glaucoma (POAG) that has completed, run by Shire. The registered enrollment target is 63 participants, below the 277-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131167, a Phase 1 study of Ocular Hypertension and Primary Open Angle Glaucoma (POAG), has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.
Conditions Studied
Interventions
- DRUG SHP639 (n=60)
- DRUG Placebo Comparator (n=24)
Study Locations (1)
Massachusetts
- Central Contact - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-05-10 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 1 |
What the finished NCT03131167 record still lists
NCT03131167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 277-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 2 interventions - of which SHP639 (n=60) is the first listed.
NCT03131167 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03131167 about?
NCT03131167 is a clinical study titled "Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma". Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.
What is the current status of trial NCT03131167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2017-05-10. Estimated completion is 2018-05-30.
What conditions does trial NCT03131167 study?
This clinical trial studies the following conditions: Ocular Hypertension, Primary Open Angle Glaucoma (POAG).
What interventions are being tested in trial NCT03131167?
The interventions under investigation include: SHP639 (n=60) (DRUG), Placebo Comparator (n=24) (DRUG).
Who is sponsoring clinical trial NCT03131167?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03131167 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03131167's enrollment target sits among peer trials
63 42nd of 54 higher than 13 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.
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