Clinical trial NCT00882687: Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])
timeFrame: Baseline to Day 7 (7 minutes post CAC 6)
measure: Ocular Itching at Day 14 (7 Minutes Post CAC 9)
timeFrame: Baseline to Day 14 (7 minutes post CAC 9)
measure: Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)
timeFrame: Baseline to Day 7 (20 minutes post CAC 6)
measure: Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)
timeFrame: Baseline to Day 14 (20 minutes post CAC 9)
Secondary outcomes:
measure: Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)
timeFrame: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC
measure: Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)
timeFrame: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: