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NCT05505292 · ClinicalTrials.gov registry record · Phase 4
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
A Phase 4 study, sponsored by State University of New York College of Optometry.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT05505292: Completed Phase 4 study, sponsored by State University of New York College of Optometry.
NCT05505292 is a Phase 4 study that has completed, run by State University of New York College of Optometry. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05505292, a Phase 4 study, has completed, sponsored by State University of New York College of Optometry.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).
Primary Outcome
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 8. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37.
Interventions
- DRUG Lifitegrast 5% Ophthalmic Solution
- OTHER Lifitegrast Ophthalmic Solution Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-09-22 |
| Est. Completion | 2023-05-15 |
| Phase | Phase 4 |
What the finished NCT05505292 record still lists
NCT05505292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Lifitegrast 5% Ophthalmic Solution is the first listed.
NCT05505292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05505292 about?
NCT05505292 is a clinical study titled "Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers". This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant ...
What is the current status of trial NCT05505292?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2022-09-22. Estimated completion is 2023-05-15.
What interventions are being tested in trial NCT05505292?
The interventions under investigation include: Lifitegrast 5% Ophthalmic Solution (DRUG), Lifitegrast Ophthalmic Solution Vehicle (OTHER).
Who is sponsoring clinical trial NCT05505292?
This trial is sponsored by State University of New York College of Optometry, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05505292's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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