Formulation Comparison in Normal Volunteers
Sponsor
Aerie Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01250197
Collaborator
(none)
18
1
2
30
18.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
Not desired.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-masked, Crossover Study Assessing the Ocular and Systemic Safety and Systemic Absorption of Two Formulations of 0.5% AR-12286 Ophthalmic Solution in Normal Volunteers
Study Start Date
:
Nov 1, 2010
Actual Primary Completion Date
:
Dec 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Formulation A AR-12286 Ophthalmic Solution Formulation A |
Drug: AR-12286
Ophthalmic Solution
|
| Experimental: Formulation B AR-12286 Ophthalmic Solution Formulation B |
Drug: AR-12286
Ophthalmic Solution
|
Outcome Measures
Primary Outcome Measures
- Ocular safety [3 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Normal volunteers
Exclusion Criteria:
- Active ophthalmic or systemic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Celerion | Phoenix | Arizona | United States | 85283 |
Sponsors and Collaborators
- Aerie Pharmaceuticals
Investigators
- Study Director: Tom van Haarlem, MD, Aerie Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01250197
Other Study ID Numbers:
- AR-12286-CS101
First Posted:
Nov 30, 2010
Last Update Posted:
Dec 22, 2010
Last Verified:
Dec 1, 2010
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