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NCT03888469 Clinical Trial

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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03888469
Other study ID # CLE383-C007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2019
Est. completion date June 24, 2019

Study information
Verified date June 2020
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date June 24, 2019
Est. primary completion date June 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key 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

Related Conditions & MeSH terms

Intervention

Device:
• Verofilcon A contact lenses
Investigational daily disposable soft contact lenses
• Etafilcon A contact lenses
Commercially available daily disposable soft contact lenses

Locations
Country Name City State
United States Alcon Investigative Site Jacksonville Florida
United States Alcon Investigative Site Maitland Florida
United States Alcon Investigative Site Memphis Tennessee
United States Alcon Investigative Site Orlando Florida
United States Alcon Investigative Site Powell Ohio

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Least Squares Mean Distance Visual Acuity With Study Lenses 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. Day 8, each product
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