Back to resultsA Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
Primary Purpose
Refractive Error, Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A contact lens
Narafilcon A contact lens
Spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error focused on measuring Contact lenses, Nearsightedness, Corneal curvature, K-reading, High minus, Spectacle refraction
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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DAILIES TOTAL1
TRUEYE
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02066922
Brief Title
A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Myopia
Keywords
Contact lenses, Nearsightedness, Corneal curvature, K-reading, High minus, Spectacle refraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAILIES TOTAL1
Arm Type
Experimental
Arm Description
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.
Arm Title
TRUEYE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lens
Other Intervention Name(s)
DAILIES® TOTAL1®
Intervention Description
Commercially available silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Narafilcon A contact lens
Other Intervention Name(s)
1-DAY ACUVUE TRUEYE™
Intervention Description
Commercially available silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Spectacles
Intervention Description
Incremental prescription worn over contact lenses if needed to provide acceptable vision
Primary Outcome Measure Information:
Title
Change in Average Central Corneal Curvature From Dispense at Week 1
Description
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.
Time Frame
Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Secondary Outcome Measure Information:
Title
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
Description
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.
Time Frame
Baseline, Week 1 (Day 8 of lens wear)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Nick, Dipl. Ing.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
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