Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis - Full Text View

Purpose

The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: Lifitegrast Other: Placebo	Phase 2


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: Prevention
Official Title:	A Phase 2, Single Center, 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 a Modified Conjunctival Allergen Challenge (CAC) Model

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Lifitegrast

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

Ocular itching and conjunctival redness at defined timepoints. [ Time Frame: Visit 4 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability in subjects with allergic conjunctivitis. [ Time Frame: Visit 3, 4, 5 and 6 ] [ Designated as safety issue: No ]


Enrollment:	60
Study Start Date:	April 2009
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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 at the time of enrollment
20/40 vision, or better, in each eye
History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

Preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, glaucoma, diabetic retinopathy, clinically significant blepharitis, follicular conjunctivitis and iritis)
Have had any ocular infection within the last 30 days
A positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears)
Any significant illness that could be expected to interfere with study parameters
Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye
Use of any investigational product or device within one month prior to Visit 1 or during the study period
Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial or within the washout period
Any blood donation or significant loss of blood within 56 days of Visit 1
Any history of autoimmune disease, immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti‑HAV IgM), or organ or bone marrow transplant. Any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis
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 3 months prior to Visit 1
Known history of alcohol abuse and/or drug abuse

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: NCT00882687

Locations


United States, Massachusetts
Ora
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Shire

Investigators


Principal Investigator:	Gail Torkildsen, MD	ORA, Inc.

More Information


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT00882687 History of Changes
Other Study ID Numbers:	1118-ACJ-100
Study First Received:	April 15, 2009
Last Updated:	April 25, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate	Hypersensitivity Immune System Diseases Ophthalmic Solutions Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 27, 2016