CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
DT1 Sphere Contact Lensesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05239494
NCT05239494N/ACompleted

How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?

University of Alabama at Birmingham·interventional·Posted Feb 15, 2022·Updated Oct 1, 2024

In Brief

A clinical study evaluating DT1 Sphere Contact Lenses for Dry Eye and Contact Lens Complication. Completed, enrolled 60 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAlcon Research

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 15, 2022
Enrollment StartMay 23, 2022
Primary CompletionAug 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.4 years ago

Interventions

DT1 Sphere Contact Lensesdevice

Devices: Dailies Total 1 Sphere Contact Lenses