A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)
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| ClinicalTrials.gov Identifier: NCT00926185 |
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Recruitment Status :
Completed
First Posted : June 23, 2009
Results First Posted : March 6, 2017
Last Update Posted : August 9, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye | Drug: Lifitegrast Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, 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 |
| Actual Study Start Date : | August 3, 2009 |
| Actual Primary Completion Date : | February 18, 2010 |
| Actual Study Completion Date : | February 18, 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Lifitegrast
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo Ophthalmic Solution
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Drug: Placebo
Ophthalmic Solution |
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Experimental: 0.1% Lifitegrast
Lifitegrast
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Drug: Lifitegrast
Ophthalmic Solution
Other Name: SAR 1118 |
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Experimental: 1.0% Lifitegrast
Lifitegrast
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Drug: Lifitegrast
Ophthalmic Solution
Other Name: SAR 1118 |
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Experimental: 5.0% Lifitegrast
Lifitegrast
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Drug: Lifitegrast
Ophthalmic Solution
Other Name: SAR 1118 |
Primary Outcome Measures :
- Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84 [ Time Frame: Day 84 ]Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Secondary Outcome Measures :
- Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84 [ Time Frame: Baseline (Day 0) and Day 84 ]Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Shire
Investigators
| Study Director: | Study Director | Takeda |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT00926185 |
| Other Study ID Numbers: |
1118-KCS-100 |
| First Posted: | June 23, 2009 Key Record Dates |
| Results First Posted: | March 6, 2017 |
| Last Update Posted: | August 9, 2021 |
| Last Verified: | August 2021 |
Keywords provided by Takeda ( Shire ):
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Dry Eye ophthalmic delivery |
Additional relevant MeSH terms:
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Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Lifitegrast Ophthalmic Solutions Pharmaceutical Solutions |