Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

Alcon Research89 enrolled

Overview

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Myopia Refractive Error

Interventions

Ultrafilcon B contact lensDEVICE

Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Stenfilcon A contact lensDEVICE

Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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, understood and signed 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 exclusion criteria may apply.

Locations (1)

Alcon Investigative Site

Surrey, United Kingdom

Outcomes

Primary Outcomes

Initial Comfort

Initial Comfort 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).

Time frame: Baseline

Secondary Outcomes

End of Day Comfort

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).

Time frame: Day 7

Overall Comfort

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).

Time frame: Day 7

Overall Handling at Time of Removal

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).

Time frame: Day 7

Data from ClinicalTrials.gov

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