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

Not Applicable

Completed

Conditions: Refractive Error
Myopia

Interventions: Device: Delefilcon A contact lens
Device: Narafilcon A contact lens
Device: Spectacles

Registration Number: NCT02066922

Lead Sponsor: Alcon Research

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

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;
Other protocol-defined inclusion criteria may apply.

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;
Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DAILIES TOTAL1	Delefilcon A contact lens	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.
DAILIES TOTAL1	Narafilcon A contact lens	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.
DAILIES TOTAL1	Spectacles	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.
TRUEYE	Spectacles	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.
TRUEYE	Delefilcon A contact lens	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.
TRUEYE	Narafilcon A contact lens	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.

Primary Outcome Measures

Name	Time	Method
Change in Average Central Corneal Curvature From Dispense at Week 1	Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)	Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.

Secondary Outcome Measures

Name	Time	Method
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1	Baseline, Week 1 (Day 8 of lens wear)	Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.