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Completed

NCT Number: NCT00882687

Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ora

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifitegrast

Drug

Ophthalmic Solution

Other names: SAR 1118

Placebo

Other

Ophthalmic Solution

Primary outcomes

  1. Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])

    Time frame: Baseline to Day 7 (7 minutes post CAC 6)

    Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.

  2. Ocular Itching at Day 14 (7 Minutes Post CAC 9)

    Time frame: Baseline to Day 14 (7 minutes post CAC 9)

    Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.

  3. Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)

    Time frame: Baseline to Day 7 (20 minutes post CAC 6)

    Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.

  4. Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)

    Time frame: Baseline to Day 14 (20 minutes post CAC 9)

    Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.

Secondary outcomes

  1. Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)

    Time frame: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC

    Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.

  2. Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)

    Time frame: Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC

    Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2009
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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