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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT02066922
First received: August 8, 2013
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Refractive Error
Myopia
Device: Delefilcon A contact lens
Device: Narafilcon A contact lens
Device: Spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in Average Central Corneal Curvature From Dispense at Week 1 [ Time Frame: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear) ] [ Designated as safety issue: No ]
    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:
  • Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 [ Time Frame: Baseline, Week 1 (Day 8 of lens wear) ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: March 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DAILIES® TOTAL1®
Device: Narafilcon A contact lens
Commercially available silicone hydrogel contact lens
Other Name: 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 Name: DAILIES® TOTAL1®
Device: Narafilcon A contact lens
Commercially available silicone hydrogel contact lens
Other Name: 1-DAY ACUVUE TRUEYE™
Device: Spectacles
Incremental prescription worn over contact lenses if needed to provide acceptable vision

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066922

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Joachim Nick, Dipl. Ing. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02066922     History of Changes
Other Study ID Numbers: C-12-057
Study First Received: August 8, 2013
Results First Received: May 26, 2015
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Alcon Research:
Contact lenses
Nearsightedness
Corneal curvature
K-reading
High minus
Spectacle refraction

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2015