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Formulation Comparison in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01250197
First received: November 29, 2010
Last updated: December 20, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Normal Volunteers
 Drug: AR-12286
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Ocular safety [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 18
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Not desired.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal volunteers

Exclusion Criteria:

  • Active ophthalmic or systemic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250197

Locations
United States, Arizona
Celerion
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
Study Director: Tom van Haarlem, MD Aerie Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Thomas van Haarlem, M.D., Aerie
ClinicalTrials.gov Identifier: NCT01250197     History of Changes
Other Study ID Numbers: AR-12286-CS101
Study First Received: November 29, 2010
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Normal Volunteers

ClinicalTrials.gov processed this record on May 16, 2013