Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®

The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia; Myopic Astigmatism
• Intervention / Treatment: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
• Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
• Those who play ball sports at least 1 day per week
• Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Those who regularly wear the study device
• Those who require ocular treatment with eye drops
• Those who have a condition contraindicating soft contact lens wear, such as eye irritation
• Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
• Those who are participating in another clinical study or research or have a plan of such participation during the present study
• Women who are pregnant or intend to become pregnant during the study
• Other protocol-defined exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DACP, then 1DAM; Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Device: Nelfilcon A contact lenses; Other Names: DACP; DAILIES® AquaComfort® Plus; Device: Etafilcon A contact lenses; Other Names: 1-DAY ACUVUE® MOIST®
Other: 1DAM, then DACP; Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Device: Nelfilcon A contact lenses; Other Names: DACP; DAILIES® AquaComfort® Plus; Device: Etafilcon A contact lenses; Other Names: 1-DAY ACUVUE® MOIST®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Investigator-Rated Lens Centration	Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.	After 1 week of wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Investigator-Rated Lens Fit	Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.	After 1 week of wear
Average Subjective Ratings Score (Lens Handling and Overall Vision)	The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.	After 1 week of wear
Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)	The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.	After 1 week of wear

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Lisa L. Zoota, MPH, CCRA, Alcon Research

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: DACP; Soft contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: M-13-050