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

NCT02103309 | Completed Results

• 1 other identifier: M-13-050
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error; Myopia; Myopic Astigmatism

Keywords

Soft contact lenses; DACP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Investigator-Rated Lens Fit

  After 1 week of wear

• Average Subjective Ratings Score (Lens Handling and Overall Vision)

  After 1 week of wear

• Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)

  After 1 week of wear

Study Arms (2)

DACP, then 1DAM

OTHER

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; Device: Etafilcon A contact lenses

1DAM, then DACP

OTHER

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; Device: Etafilcon A contact lenses

Interventions

Nelfilcon A contact lenses DEVICE

Also known as: DAILIES® AquaComfort® Plus, DACP

1DAM, then DACP; DACP, then 1DAM

Etafilcon A contact lenses DEVICE

Also known as: 1-DAY ACUVUE® MOIST®

1DAM, then DACP; DACP, then 1DAM

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Alcon Japan, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Lisa L. Zoota, MPH, CCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 3, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 29, 2014
• Results First Posted: October 29, 2014

Record last verified: 2014-10