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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103309
• Other study ID #: M-13-050
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: October 24, 2014
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: October 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Myopic Astigmatism
• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A contact lenses

• Etafilcon A contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No