A Clinical Comparison of Two Daily Disposable Contact Lenses.
- Conditions
- Myopia
- Interventions
- Device: etafilcon ADevice: nelfilcon A
- Registration Number
- NCT00775021
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
-
Age: 18 years to 45 years
-
Current daily soft contact lens as habitual optical correction:
-
Refraction:
- Best sphere (corrected for back vertex distance) -1.00 to -6.00D
- Cylinder 0.00 to - 0.75D
-
Best spectacle corrected visual acuity of 6/9 or better in each eye
-
Willingness to adhere to the instructions set in the clinical protocol
-
Signature of the subject on the informed consent form
- Systemic or ocular allergies which might interfere with contact lens wear
- Systemic disease which might interfere with contact lens wear
- Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
- Use of medication which might interfere with contact lens wear
- Active ocular infection
- Use of ocular medication
- Significant ocular anomaly
- Presence of two or more corneal scars in either eye
- Pregnancy or lactation
- Any medical condition that might be prejudicial to the study
- Participated in any other clinical studies in the past month
- Currently wears monovision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description etafilcon A/nelfilcon A etafilcon A etafilcon A contact lens worn first and nelfilcon A contact lens worn second etafilcon A/nelfilcon A nelfilcon A etafilcon A contact lens worn first and nelfilcon A contact lens worn second nelfilcon A/etafilcon A nelfilcon A nelfilcon A contact lens worn first and etafilcon A contact lens second. nelfilcon A/etafilcon A etafilcon A nelfilcon A contact lens worn first and etafilcon A contact lens second.
- Primary Outcome Measures
Name Time Method Overall Comfort 1 week Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
- Secondary Outcome Measures
Name Time Method Inferior Region Corneal Staining 1 week The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (\>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (\>5-10 spots) 6 = Severe macropunctate (\>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (\>2-4mm) 9 = Severe patch (\>4mm)
End of the Day Comfort 1 week Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Initial Comfort 1 Week Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Overall Lens Handling 1 week Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Trial Locations
- Locations (1)
Otometry Technology Group, Ltd.
🇬🇧London, United Kingdom