One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: comfilcon A sphere lens (control); Device: comfilcon A asphere lens (test)

• Registration Number: NCT02759471
• Lead Sponsor: Coopervision, Inc.

Brief Summary

This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Detailed Description

This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Results First Submitted: 2017-01-03
• Results First Submitted QC: 2017-01-03
• Results First Posted: 2017-02-23
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
comfilcon A sphere (control)	comfilcon A sphere lens (control)	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
comfilcon A asphere (test)	comfilcon A asphere lens (test)	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).

Primary Outcome Measures

Name	Time	Method
Lens Fit - Centration	baseline, 2 weeks, 1 month	Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).
Lens Fit - Post-blink Movement	baseline, 2 weeks, 1 month	Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Preference/Acceptability	baseline, 2 weeks, 1 month	Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).
Lens Fit - Corneal Coverage	baseline, 2 weeks, 1 month	Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).

Trial Locations

Locations (4)

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

Drs. Quinn, Foster, & Associates; 🇺🇸 Athens, Ohio, United States