Refractive Error
Conditions
Keywords
contact lenses, daily disposable contact lenses, silicone hydrogel, contact lens comfort, near-sighted
Brief summary
The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.
Interventions
DEVICENelfilcon A contact lens
Soft contact lens CE-marked for daily disposable wear.
Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Adapted soft contact lens wearer; * Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive); * Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other; * Correctable to 6/9 (20/30) in both eyes; * Read, understand, and sign the informed consent; * Willing to comply with the wear schedule; * Willing to comply with the study visit schedule; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any active corneal infection, injury or inflammation; * Systemic or ocular allergies which might interfere with contact lens wear; * Systemic or ocular disease which might interfere with contact lens wear; * Strabismus or amblyopia; * Corneal refractive surgery and any anterior segment surgery; * Use of systemic/topical medication contraindicating contact lens wear; * Use of gas permeable contact lenses within 1 month preceding the study; * Participation in any concurrent clinical trial or in the last 30 days; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial comfort | Baseline | Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End of Day Comfort | Day 7 | End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful). |
| Overall Comfort | Day 7 | Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful). |
| Overall Handling at Time of Removal | Day 7 | Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable). |
Countries
United Kingdom
Outcome results
None listed