Clinical trial NCT01421498: Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
Official title: A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Dry Eye Disease
Keywords: ophthalmic delivery
Dry Eye
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Willing and able to read, sign, and date the informed consent and HIPAA documents
* 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 artificial tear substitutes) 72 hrs prior to Visit 1 and during the study
* Any significant chronic 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
* Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)

Primary outcomes:
measure: Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84
timeFrame: Baseline (Day 0) to Day 84
measure: Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84
timeFrame: Baseline (Day 0) to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: OPUS-1 Investigational Site
state: Connecticut
city: Louisville
country: United States
facility: OPUS-1 Investigational Site
state: Kentucky
city: Augusta
country: United States
facility: OPUS-1 Investigational Site
state: Maine
city: Lewiston
country: United States
facility: OPUS-1 Investigational Site
state: Maine
city: Andover
country: United States
facility: OPUS-1 Investigational Site
state: Massachusetts
city: Lancaster
country: United States
facility: OPUS-1 Investigational Site
state: Massachusetts
city: Quincy
country: United States
facility: OPUS-1 Investigational Site
state: Massachusetts
city: Wakefield
country: United States
facility: OPUS-1 Investigational Site
state: Massachusetts
city: Winchester
country: United States
facility: OPUS-1 Investigational Site
state: Massachusetts
city: Derry
country: United States
facility: OPUS-1 Investigational Site
state: New Hampshire
city: Manchester
country: United States
facility: OPUS-1 Investigational Site
state: New Hampshire
city: Memphis
country: United States
facility: OPUS-1 Investigational Site
state: Tennessee
city: Norfolk
country: United States
facility: OPUS-1 Investigational Site
state: Virginia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Sheppard JD, Torkildsen GL, Lonsdale JD, D'Ambrosio FA Jr, McLaurin EB, Eiferman RA, Kennedy KS, Semba CP; OPUS-1 Study Group. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study. Ophthalmology. 2014 Feb;121(2):475-83. doi: 10.1016/j.ophtha.2013.09.015. Epub 2013 Nov 26.