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

Not Applicable

Completed

• Conditions: Myopia; Myopic Astigmatism; Refractive Error

• Registration Number: NCT02103309
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-03
• Status Verified: 2014-10
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-10-24
• Last Update Submitted: 2014-10-24
• Results First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mean Investigator-Rated Lens Centration	After 1 week of wear	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.

Secondary Outcome Measures

Name	Time	Method
Average Subjective Ratings Score (Lens Handling and Overall Vision)	After 1 week of wear	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.
Mean Investigator-Rated Lens Fit	After 1 week of wear	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.
Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)	After 1 week of wear	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.