A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects

NCT ID: NCT02066922

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.

Detailed Description

Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.

Conditions

Refractive Error; Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DAILIES TOTAL1

Delefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision.

Group Type: EXPERIMENTAL

Delefilcon A contact lens

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lens

Narafilcon A contact lens

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lens

Spectacles

Intervention Type: DEVICE

Incremental prescription worn over contact lenses if needed to provide acceptable vision

TRUEYE

Narafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision.

Group Type: ACTIVE_COMPARATOR

Delefilcon A contact lens

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lens

Narafilcon A contact lens

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lens

Spectacles

Intervention Type: DEVICE

Incremental prescription worn over contact lenses if needed to provide acceptable vision

Interventions

Delefilcon A contact lens

Commercially available silicone hydrogel contact lens

Intervention Type: DEVICE

Narafilcon A contact lens

Commercially available silicone hydrogel contact lens

Intervention Type: DEVICE

Spectacles

Incremental prescription worn over contact lenses if needed to provide acceptable vision

Intervention Type: DEVICE

Other Intervention Names

DAILIES® TOTAL1®; 1-DAY ACUVUE TRUEYE™

Eligibility Criteria

Inclusion Criteria

• Sign Informed Consent document;
• Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;
• Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);
• Manifest astigmatism less than or equal to -1.00D;
• Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;

Exclusion Criteria

• Pregnant or lactating;
• Eye injury or surgery within twelve weeks immediately prior to enrollment;
• Any ocular condition that contraindicates contact lens wear;
• History of herpetic keratitis;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;
• Clinical significant dry eye not responding to treatment;
• Previous corneal or refractive surgery or irregular cornea;
• Requires reading glasses;
• Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days;
• Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Nick, Dipl. Ing.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-057

Identifier Type: -

Identifier Source: org_study_id