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
  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
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 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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014