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NCT02347631 · ClinicalTrials.gov registry record · NA
DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin
A NA study of Myopia and Soft Contact Lenses, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT02347631: Completed NA study of Myopia and Soft Contact Lenses, sponsored by University of Texas Southwestern Medical Center.
NCT02347631 is a NA study of Myopia and Soft Contact Lenses that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 118 participants, below the 267-participant average among 90 other Myopia trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02347631, a NA study of Myopia and Soft Contact Lenses, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, single center, randomized, bilateral crossover, dispensing clinical trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of corneal epithelium over two months of daily wear compared to wear of a control high oxygen permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to correlate these changes with alterations in the lid wiper, tear film and cellular changes at the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up to 94 established contact lens wearers, with anticipated completion of 84. Data will be collected at baseline and following 2 months of daily wear for each lens type. Based upon data from the investigators previous contact lens clinical trials, a 1 month washout period is required prior to initiating lens wear and also between lens wear periods for the two types of lenses in order to eliminate any potential residual solution or lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to commence upon Institutional Review Board approval.
Primary Outcome
Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing AcuVue TRUEYE contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Acuvue TRUEYE con
Conditions Studied
Interventions
- DEVICE Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye
- DEVICE Soft Contact Lens - Acuvue TruEye and Alcon DAILIES TOTAL 1.
Study Locations (1)
Texas
- Aston Ambulatory Care Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2016-04 |
| Est. Completion | 2018-06 |
| Phase | NA |
What the finished NCT02347631 record still lists
NCT02347631 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 267-participant average among 90 other Myopia trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Myopia appearing as the primary indexed condition, and to 2 interventions - of which Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye is the first listed.
NCT02347631 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02347631 about?
NCT02347631 is a clinical study titled "DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin". This is a prospective, single center, randomized, bilateral crossover, dispensing clinical trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of corneal epithelium over two months of daily wear compared to wear of a control high oxygen permeable silicone hydroge...
What is the current status of trial NCT02347631?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2016-04. Estimated completion is 2018-06.
What conditions does trial NCT02347631 study?
This clinical trial studies the following conditions: Myopia, Soft Contact Lenses.
What interventions are being tested in trial NCT02347631?
The interventions under investigation include: Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye (DEVICE), Soft Contact Lens - Acuvue TruEye and Alcon DAILIES TOTAL 1. (DEVICE).
Who is sponsoring clinical trial NCT02347631?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02347631 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02347631's enrollment target sits among peer trials
118 34th of 90 higher than 57 of 90 other Myopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myopia 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.
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