Formulation Comparison in Normal Volunteers
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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 22, 2010
December 1, 2010
1 month
November 29, 2010
December 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular safety
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.
3 weeks
Study Arms (2)
Formulation A
EXPERIMENTALAR-12286 Ophthalmic Solution Formulation A
Formulation B
EXPERIMENTALAR-12286 Ophthalmic Solution Formulation B
Interventions
Eligibility Criteria
You may qualify if:
- Normal volunteers
You may not qualify if:
- Active ophthalmic or systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Phoenix, Arizona, 85283, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Tom van Haarlem, MD
Aerie Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 29, 2010
First Posted
November 30, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 22, 2010
Record last verified: 2010-12