A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01743729 |
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Recruitment Status :
Completed
First Posted : December 6, 2012
Results First Posted : February 24, 2017
Last Update Posted : June 23, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Dry Eye Disease |
| Interventions |
Drug: Lifitegrast Drug: Placebo |
| Enrollment | 720 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Two of 720 participants were excluded from data analysis due to duplication. Therefore, 718 participants were randomized and treated. One participant from placebo arm (N=360) has taken study drug by mistake and considered for "Lifitegrast" arm (N=358). Therefore, Placebo (N=359), Lifitegrast (N=359) were considered for safety analysis. |
| Arm/Group Title | Lifitegrast | Placebo |
|---|---|---|
 Arm/Group Description |
[Not Specified] | [Not Specified] |
| Period Title: Overall Study | ||
| Started | 358 [1] | 360 [2] |
| Completed | 321 | 348 |
| Not Completed | 37 | 12 |
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[1]
One participant from placebo arm included in Lifitegrast arm for safety analysis set (N=359).
[2]
One placebo participant was considered for Lifitegrast arm; Placebo safety analysis set (N= 359).
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Baseline Characteristics
| Arm/Group Title | Lifitegrast | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
[Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 358 | 360 | 718 | |
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Baseline Analysis Population Description |
Randomized population.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 358 participants | 360 participants | 718 participants | |
| 58.7 (13.93) | 58.9 (14.26) | 58.8 (14.09) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 358 participants | 360 participants | 718 participants | |
| Female |
285 79.6%
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265 73.6%
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550 76.6%
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| Male |
73 20.4%
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95 26.4%
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168 23.4%
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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 |
| Responsible Party: | Takeda ( Shire ) |
| ClinicalTrials.gov Identifier: | NCT01743729 |
| Other Study ID Numbers: |
1118-DRY-300 |
| First Submitted: | December 3, 2012 |
| First Posted: | December 6, 2012 |
| Results First Submitted: | August 9, 2016 |
| Results First Posted: | February 24, 2017 |
| Last Update Posted: | June 23, 2021 |