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NCT03682809 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
A Phase 4 study of Dry Eye and Contact Lens Discomfort, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
- 3
- Study locations
NCT03682809: Completed Phase 4 study of Dry Eye and Contact Lens Discomfort, sponsored by University of Alabama at Birmingham.
NCT03682809 is a Phase 4 study of Dry Eye and Contact Lens Discomfort that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 46 participants, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (52% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03682809, a Phase 4 study of Dry Eye and Contact Lens Discomfort, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
- 3
- Study locations
Study Summary
Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CL discomfort. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of patients who have CL discomfort.
Primary Outcome
Improvement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being t
Conditions Studied
Interventions
- DRUG Systane Complete
Study Locations (3)
Alabama
- University of Alabama at Birmingham - Birmingham
New York
- Lindenhurst Eye Physicians & Surgeons, P.C. - Babylon
Tennessee
- Southern College of Optometry - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2019-03-23 |
| Phase | Phase 4 |
What the finished NCT03682809 record still lists
NCT03682809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (52% lower).
The record links to 2 conditions, with Dry Eye appearing as the primary indexed condition, and to 1 intervention - of which Systane Complete is the first listed.
NCT03682809 reports a single indexed study location in Alabama, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03682809 about?
NCT03682809 is a clinical study titled "Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort". Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that usi...
What is the current status of trial NCT03682809?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2018-11-19. Estimated completion is 2019-03-23.
What conditions does trial NCT03682809 study?
This clinical trial studies the following conditions: Dry Eye, Contact Lens Discomfort.
What interventions are being tested in trial NCT03682809?
The interventions under investigation include: Systane Complete (DRUG).
Who is sponsoring clinical trial NCT03682809?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03682809 being conducted?
This trial has 3 study locations across Alabama, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03682809's enrollment target sits among peer trials
46 22nd of 41 higher than 20 of 41 other Dry Eye trials
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