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NCT05239494 · ClinicalTrials.gov registry record · NA
Dailies Total 1 Sphere Contact Lenses
A NA study of Dry Eye and Contact Lens Complication, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT05239494 is a NA study of Dry Eye and Contact Lens Complication that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 60 participants, below the 94-participant average among 41 other Dry Eye trials with a reported enrollment target (36% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05239494, a NA study of Dry Eye and Contact Lens Complication, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study Summary
CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years. Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.
Conditions Studied
Interventions
- DEVICE DT1 Sphere Contact Lenses
Study Locations (4)
Alabama
- University of Alabama at Birmingham - Birmingham
Kansas
- Kannarr Eye Care - Pittsburg
Ohio
- ProCare Vision Center - Granville
Tennessee
- The Southern College of Optometry - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2023-08-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05239494
The ClinicalTrials.gov registry entry for NCT05239494 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 41 other Dry Eye trials with a reported enrollment target (36% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dry Eye appearing as the primary indexed condition, and to 1 intervention - of which DT1 Sphere Contact Lenses is the first listed.
NCT05239494 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Alabama, Kansas, Ohio.
Frequently Asked Questions
What is clinical trial NCT05239494 about?
NCT05239494 is a clinical study titled "Dailies Total 1 Sphere Contact Lenses". CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturba...
What is the current status of trial NCT05239494?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-05-23. Estimated completion is 2023-08-30.
What conditions does trial NCT05239494 study?
This clinical trial studies the following conditions: Dry Eye, Contact Lens Complication.
What interventions are being tested in trial NCT05239494?
The interventions under investigation include: DT1 Sphere Contact Lenses (DEVICE).
Who is sponsoring clinical trial NCT05239494?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05239494 being conducted?
This trial has 4 study locations across Alabama, Kansas, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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