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Formulation Comparison in Normal Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01250197
First Posted: November 30, 2010
Last Update Posted: December 22, 2010
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.
Information provided by:
Aerie Pharmaceuticals
  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
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

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Normal volunteers

Exclusion Criteria:

  • Active ophthalmic or systemic disease
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thomas van Haarlem, M.D., Aerie
ClinicalTrials.gov Identifier: NCT01250197     History of Changes
Other Study ID Numbers: AR-12286-CS101
First Submitted: November 29, 2010
First Posted: November 30, 2010
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