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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 29, 2010

Last Updated Date

December 20, 2010

Start Date ^ICMJE

November 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01250197 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Formulation Comparison in Normal Volunteers

Official Title ^ICMJE

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

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.

Detailed Description

Not desired.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Normal Volunteers

Intervention ^ICMJE

Drug: AR-12286

Ophthalmic Solution

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Normal volunteers

Exclusion Criteria:

Active ophthalmic or systemic disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01250197

Other Study ID Numbers ^ICMJE

AR-12286-CS101

Has Data Monitoring Committee

Responsible Party

Thomas van Haarlem, M.D., Aerie

Study Sponsor ^ICMJE

Aerie Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tom van Haarlem, MD

Aerie Pharmaceuticals, Inc.

Information Provided By

Aerie Pharmaceuticals

Verification Date

December 2010

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

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