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

NCT02066922 | Completed Results

• 1 other identifier: C-12-057
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error; Myopia

Keywords

Contact lenses; Nearsightedness; Corneal curvature; K-reading; High minus; Spectacle refraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

DAILIES TOTAL1

EXPERIMENTAL

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; Device: Narafilcon A contact lens; Device: Spectacles

TRUEYE

ACTIVE COMPARATOR

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; Device: Narafilcon A contact lens; Device: Spectacles

Interventions

Delefilcon A contact lens DEVICE

Commercially available silicone hydrogel contact lens

Also known as: DAILIES® TOTAL1®

DAILIES TOTAL1; TRUEYE

Narafilcon A contact lens DEVICE

Commercially available silicone hydrogel contact lens

Also known as: 1-DAY ACUVUE TRUEYE™

DAILIES TOTAL1; TRUEYE

Spectacles DEVICE

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

DAILIES TOTAL1; TRUEYE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Clinical Lead, Vision Care Development
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Joachim Nick, Dipl. Ing.

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: February 20, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-05