Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

Not Applicable

Completed

• Conditions: Refractive Error; Myopia
• Interventions: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses

• Registration Number: NCT03888469
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.

Detailed Description

Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Study Start: 2019-05-03
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Results First Submitted: 2020-05-29
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-22
• Results First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
• Willing and able to attend all scheduled study visits as required per protocol.
• Current wearer of spherical soft contact lenses.

Key

Exclusion Criteria

• Any ocular condition that contraindicates contact lens wear.
• Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1DAVM, then DDT2	Verofilcon A contact lenses	Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
DDT2, then 1DAVM	Verofilcon A contact lenses	Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
1DAVM, then DDT2	Etafilcon A contact lenses	Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
DDT2, then 1DAVM	Etafilcon A contact lenses	Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance Visual Acuity With Study Lenses	Day 8, each product	Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Trial Locations

Locations (1)

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