Trial · NCT01421498
Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
NCT01421498, Phase 3, Completed, Shire; results first posted 2017-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1). Trials, record NCT01421498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01421498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
- NCT number
- NCT01421498
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 588 participants, actual
- Lead sponsor
- Shire
- Conditions
- Keratoconjunctivitis Sicca, Dry Eye Disease
- Interventions
- Lifitegrast, Placebo
- First posted
- 2011-08-22
- Last updated
- 2021-06-11
- Results first posted
- 2017-02-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84 | 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. |
| Primary | Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84 | Baseline (Day 0) to Day 84 | Intent-to-Treat (ITT) population with Last Observation Carried Forward (LOCF) included all randomized participants who received at least 1 dose of investigational product. | units on a scale | MEAN |
| PRIMARY | Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84 | Baseline (Day 0) to Day 84 | ITT population with LOCF. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84 | Lifitegrast 5.0% | -0.07 | Standard Deviation 0.868 | units on a scale | |
| Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84 | Placebo | 0.17 | Standard Deviation 0.819 | units on a scale | |
| Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84 | Lifitegrast 5.0% | -0.11 | Standard Deviation 0.829 | units on a scale | |
| Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84 | Placebo | -0.12 | Standard Deviation 0.762 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lifitegrast 5.0% | 293 | |
| Overall Study | STARTED | Placebo | 295 | |
| Overall Study | COMPLETED | Lifitegrast 5.0% | 281 | |
| Overall Study | COMPLETED | Placebo | 284 | |
| Overall Study | NOT COMPLETED | Lifitegrast 5.0% | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Visual acuity reduced | Eye disorders | Lifitegrast 5.0% | 14 | 293 | 17 |
| other | Visual acuity reduced | Eye disorders | Placebo | 15 | 295 | 18 |
| other | Instillation site irritation | General disorders | Lifitegrast 5.0% | 69 | 293 | 70 |
| other | Instillation site irritation | General disorders | Placebo | 12 | 295 | 12 |
| other | Instillation site pain | General disorders | Lifitegrast 5.0% | 63 | 293 | 63 |
| other | Instillation site pain | General disorders | Placebo | 11 | 295 | 11 |
| other | Instillation site pruritus | General disorders | Lifitegrast 5.0% | 19 | 293 | 19 |
| other | Instillation site pruritus | General disorders | Placebo | 6 | 295 | 6 |
| other | Instillation site reaction | General disorders | Lifitegrast 5.0% | 50 | 293 | 52 |
| other | Instillation site reaction | General disorders | Placebo | 2 | 295 | 2 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lifitegrast 5.0% | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lifitegrast 5.0% | 160 | 293 |
| Total, other adverse events | Placebo | 40 | 295 |
| Total, serious adverse events | Lifitegrast 5.0% | 5 | 293 |
| Total, serious adverse events | Placebo | 2 | 295 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24289915 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lifitegrast 5.0% vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01421498
GET https://conductscience.org/api/trials/v1/NCT01421498/events?page=2