Performance Assessment of a Modified Daily Disposable Contact Lens

Not Applicable

Completed

• Conditions: Refractive Errors; Myopia; Hyperopia
• Interventions: Device: Modified delefilcon A contact lenses; Device: Delefilcon A contact lenses

• Registration Number: NCT03762668
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Detailed Description

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Study Timeline

• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-01
• Study Start: 2018-12-03
• Study First Posted: 2018-12-04
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Results First Submitted: 2019-12-19
• Results First Submitted QC: 2019-12-19
• Status Verified: 2020-01
• Results First Posted: 2020-01-07
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Able to understand and sign an approved Informed Consent form;
• Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
• Monocular (only one eye with functional vision);
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MDACL, then DACL	Modified delefilcon A contact lenses	Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
DACL, then MDACL	Modified delefilcon A contact lenses	DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
DACL, then MDACL	Delefilcon A contact lenses	DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
MDACL, then DACL	Delefilcon A contact lenses	Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
High Contrast Distance Visual Acuity (logMAR)	Day 1 Dispense, Day 7 Follow-Up	Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Memphis, Tennessee, United States