Formulation Comparison in Normal Volunteers

Phase 1

Completed

• Conditions: Normal Volunteers
• Interventions: Drug: AR-12286

• Registration Number: NCT01250197
• Lead Sponsor: Aerie Pharmaceuticals

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.

Detailed Description

Not desired.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-20
• Last Update Posted: 2010-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Normal volunteers

Exclusion Criteria

• Active ophthalmic or systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation A	AR-12286	AR-12286 Ophthalmic Solution Formulation A
Formulation B	AR-12286	AR-12286 Ophthalmic Solution Formulation B

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Celerion; 🇺🇸 Phoenix, Arizona, United States