A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye - Full Text View

Sponsor:	SARcode Bioscience
Information provided by:	SARcode Bioscience
ClinicalTrials.gov Identifier:	NCT00926185

Purpose

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Condition	Intervention	Phase
Dry Eye	Drug: SAR 1118 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model

Further study details as provided by SARcode Bioscience:

Primary Outcome Measures:

Sign: Corneal fluorescein staining before CAE exposure [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms: Ocular symptoms pre- and post-chamber [ Time Frame: Prospective ] [ Designated as safety issue: No ]
Signs: Ocular Signs pre- & post-chamber; Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, TFBUT, blink rate, OPI, STT & corneal sensitivity [ Time Frame: Prospective ] [ Designated as safety issue: No ]
Safety across treatment groups [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Enrollment:	230
Study Start Date:	June 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo Ophthalmic Solution	Drug: Placebo Ophthalmic Solution
Experimental: 0.1% SAR 1118	Drug: SAR 1118 Ophthalmic Solution
Experimental: 1.0% SAR 1118	Drug: SAR 1118 Ophthalmic Solution
Experimental: 5.0% SAR 1118	Drug: SAR 1118 Ophthalmic Solution

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent Form and HIPAA document
Willing and able to comply with all study procedures
Be at least 18 years of age
Patient-reported history of dry eye in both eyes
Demonstrate a positive response when exposed to the Controlled Adverse Environment model
A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period
Any blood donation or significant loss of blood within 56 days of Visit 1
Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
Use of any topical ophthalmic preparations (including tear substitutes) 72 hrs prior to screening assessments and through the entire study period
Any significant illness that could interfere with study parameters
History of laser‑assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
Known history of alcohol and/or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926185

Locations

United States, Connecticut
The Eye Care Group
Waterbury, Connecticut, United States, 06708
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04243
United States, Massachusetts
Ora, Inc. (two locations)
Andover, Massachusetts, United States, 01840
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119

Sponsors and Collaborators

SARcode Bioscience

Investigators

Principal Investigator:

Gail Torkildsen, MD

ORA, Inc.

More Information

No publications provided

Responsible Party:	Director of Clinical Operations, SARcode
ClinicalTrials.gov Identifier:	NCT00926185 History of Changes
Other Study ID Numbers:	1118-KCS-100
Study First Received:	June 20, 2009
Last Updated:	March 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by SARcode Bioscience:

Dry Eye
ophthalmic delivery

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases

Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on February 09, 2012