Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01917162

C-13-033

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Nelfilcon A/UltraFilcon B

Other group

Description:

Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Treatment:

Device: UltraFilcon B contact lens

Device: Nelfilcon A contact lens

UltraFilcon B/Nelfilcon A

Other group

Description:

UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Treatment:

Device: UltraFilcon B contact lens

Device: Nelfilcon A contact lens