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

November 29, 2010
December 20, 2010
November 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01250197 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Formulation Comparison in Normal Volunteers
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

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.

Not desired.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Normal Volunteers
Drug: AR-12286
Ophthalmic Solution
  • Experimental: Formulation A
    AR-12286 Ophthalmic Solution Formulation A
    Intervention: Drug: AR-12286
  • Experimental: Formulation B
    AR-12286 Ophthalmic Solution Formulation B
    Intervention: Drug: AR-12286
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal volunteers

Exclusion Criteria:

  • Active ophthalmic or systemic disease
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250197
AR-12286-CS101
No
Thomas van Haarlem, M.D., Aerie
Aerie Pharmaceuticals
Not Provided
Study Director: Tom van Haarlem, MD Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP