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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Spectacles

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Delefilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: DAILIES® TOTAL1®; Device: Narafilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: 1-DAY ACUVUE TRUEYE™; Device: Spectacles; Incremental prescription worn over contact lenses if needed to provide acceptable vision
Active Comparator: 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.	Device: Delefilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: DAILIES® TOTAL1®; Device: Narafilcon A contact lens; Commercially available silicone hydrogel contact lens; Other Names: 1-DAY ACUVUE TRUEYE™; Device: Spectacles; Incremental prescription worn over contact lenses if needed to provide acceptable vision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Central Corneal Curvature From Dispense at Week 1	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.	Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1	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.	Baseline, Week 1 (Day 8 of lens wear)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Joachim Nick, Dipl. Ing., Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Contact lenses; Nearsightedness; Corneal curvature; K-reading; High minus; Spectacle refraction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C-12-057