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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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Dry Eye |
| Interventions |
Drug: Lifitegrast Drug: Placebo |
| Enrollment | 230 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | The study was conducted in a Controlled Adverse Environment (CAE). |
| Arm/Group Title | Lifitegrast 0.1% | Lifitegrast 1.0% | Lifitegrast 5.0% | Placebo |
|---|---|---|---|---|
 Arm/Group Description |
[Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] |
| Period Title: Overall Study | ||||
| Started | 57 | 57 | 58 | 58 |
| Completed | 54 | 51 | 48 | 48 |
| Not Completed | 3 | 6 | 10 | 10 |
Baseline Characteristics
| Arm/Group Title | Lifitegrast 0.1% | Lifitegrast 1.0% | Lifitegrast 5.0% | Placebo | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
[Not Specified] | [Not Specified] | [Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 57 | 57 | 58 | 58 | 230 | |
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Baseline Analysis Population Description |
Intent-to-treat (ITT) set included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 57 participants | 57 participants | 58 participants | 58 participants | 230 participants | |
| 63.14 (13.100) | 63.63 (11.883) | 62.26 (12.220) | 60.38 (12.930) | 62.34 (12.523) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 57 participants | 57 participants | 58 participants | 58 participants | 230 participants | |
| Female |
47 82.5%
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40 70.2%
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47 81.0%
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45 77.6%
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179 77.8%
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| Male |
10 17.5%
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17 29.8%
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11 19.0%
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13 22.4%
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51 22.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If a multicentre publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicentre Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Shire (Note: Lifitegrast was divested to Novartis in 2019) |
| Phone: | +1 866 842 5335 |
| EMail: | ClinicalTransparency@shire.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Takeda ( Shire ) |
| ClinicalTrials.gov Identifier: | NCT00926185 |
| Other Study ID Numbers: |
1118-KCS-100 |
| First Submitted: | June 20, 2009 |
| First Posted: | June 23, 2009 |
| Results First Submitted: | August 9, 2016 |
| Results First Posted: | March 6, 2017 |
| Last Update Posted: | August 9, 2021 |