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Formulation Comparison in Normal Volunteers

This study has been completed.
Information provided by:
Aerie Pharmaceuticals Identifier:
First received: November 29, 2010
Last updated: December 20, 2010
Last verified: December 2010
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

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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01250197

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

Responsible Party: Thomas van Haarlem, M.D., Aerie Identifier: NCT01250197     History of Changes
Other Study ID Numbers: AR-12286-CS101
Study First Received: November 29, 2010
Last Updated: December 20, 2010

Keywords provided by Aerie Pharmaceuticals:
Normal Volunteers

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions processed this record on September 21, 2017