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NCT01250197 · ClinicalTrials.gov registry record · Phase 1
Formulation Comparison in Normal Volunteers
A Phase 1 study of Normal Volunteers, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01250197: Completed Phase 1 study of Normal Volunteers, sponsored by Aerie Pharmaceuticals.
NCT01250197 is a Phase 1 study of Normal Volunteers that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 18 participants, below the 1,458-participant average among 4 other Normal Volunteers trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250197, a Phase 1 study of Normal Volunteers, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.
Primary Outcome
The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.
Conditions Studied
Interventions
- DRUG AR-12286
Study Locations (1)
Arizona
- Celerion - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-11 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT01250197 record still lists
NCT01250197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,458-participant average among 4 other Normal Volunteers trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Normal Volunteers appearing as the primary indexed condition, and to 1 intervention - of which AR-12286 is the first listed.
NCT01250197 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01250197 about?
NCT01250197 is a clinical study titled "Formulation Comparison in Normal Volunteers". This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.
What is the current status of trial NCT01250197?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-11. Estimated completion is 2010-12.
What conditions does trial NCT01250197 study?
This clinical trial studies the following conditions: Normal Volunteers.
What interventions are being tested in trial NCT01250197?
The interventions under investigation include: AR-12286 (DRUG).
Who is sponsoring clinical trial NCT01250197?
This trial is sponsored by Aerie Pharmaceuticals, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01250197 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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