Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Initial comfort
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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 exclusion criteria may apply.
Arms & Interventions
Nelfilcon A/UltraFilcon B
Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Intervention: Nelfilcon A contact lens (Device)
Nelfilcon A/UltraFilcon B
Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Intervention: UltraFilcon B contact lens (Device)
UltraFilcon B/Nelfilcon A
UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Intervention: Nelfilcon A contact lens (Device)
UltraFilcon B/Nelfilcon A
UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Intervention: UltraFilcon B contact lens (Device)
Outcomes
Primary Outcomes
Initial comfort
Time Frame: 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 Outcomes
- End of Day Comfort(Day 7)
- Overall Comfort(Day 7)
- Overall Handling at Time of Removal(Day 7)