Formulation Comparison in Normal Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250197
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : December 22, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Normal Volunteers Drug: AR-12286 Phase 1

Detailed Description:
Not desired.

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Ocular safety [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal volunteers

Exclusion Criteria:

  • Active ophthalmic or systemic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250197

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

Responsible Party: Thomas van Haarlem, M.D., Aerie Identifier: NCT01250197     History of Changes
Other Study ID Numbers: AR-12286-CS101
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010

Keywords provided by Aerie Pharmaceuticals:
Normal Volunteers

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions