Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
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| ClinicalTrials.gov Identifier: NCT01421498 |
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Recruitment Status :
Completed
First Posted : August 22, 2011
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
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Sponsor:
Shire
Information provided by (Responsible Party):
Shire
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Keratoconjunctivitis Sicca | Drug: Lifitegrast Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 588 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | August 2011 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Lifitegrast
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 5.0% Lifitegrast
Lifitegrast
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Drug: Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Other Name: SAR 1118 |
| Placebo Comparator: Placebo |
Drug: Placebo
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks |
Primary Outcome Measures :
- Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84 [ Time Frame: Baseline (Day 0) to 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/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) 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.
- Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84 [ Time Frame: Baseline (Day 0) to Day 84 ]The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision [Items 1-5]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television [Items 6-9]), and environmental triggers (windy conditions, low humidity, air conditioning [Items 10-12]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.
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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:
- 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)
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): NCT01421498
Locations
| United States, Connecticut | |
| OPUS-1 Investigational Site | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Kentucky | |
| OPUS-1 Investigational Site | |
| Louisville, Kentucky, United States, 40405 | |
| United States, Maine | |
| OPUS-1 Investigational Site | |
| Augusta, Maine, United States, 04330 | |
| OPUS-1 Investigational Site | |
| Lewiston, Maine, United States, 04243 | |
| United States, Massachusetts | |
| OPUS-1 Investigational Site | |
| Andover, Massachusetts, United States, 01840 | |
| OPUS-1 Investigational Site | |
| Lancaster, Massachusetts, United States, 01523 | |
| OPUS-1 Investigational Site | |
| Quincy, Massachusetts, United States, 02169 | |
| OPUS-1 Investigational Site | |
| Wakefield, Massachusetts, United States, 01880 | |
| OPUS-1 Investigational Site | |
| Winchester, Massachusetts, United States, 01890 | |
| United States, New Hampshire | |
| OPUS-1 Investigational Site | |
| Derry, New Hampshire, United States, 03038 | |
| OPUS-1 Investigational Site | |
| Manchester, New Hampshire, United States, 03101 | |
| United States, Tennessee | |
| OPUS-1 Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Virginia | |
| OPUS-1 Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
Sponsors and Collaborators
Shire
Investigators
| Study Director: | Charles Semba, MD | SARcode Bioscience, Inc. |
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT01421498 History of Changes |
| Other Study ID Numbers: |
1118-KCS-200 |
| First Posted: | August 22, 2011 Key Record Dates |
| Results First Posted: | February 24, 2017 |
| Last Update Posted: | February 24, 2017 |
| Last Verified: | January 2017 |
Keywords provided by Shire:
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Dry Eye ophthalmic delivery |
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases |
Keratitis Corneal Diseases Lacrimal Apparatus Diseases Ophthalmic Solutions Lifitegrast Pharmaceutical Solutions |