Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

Alcon

Status: Completed

Conditions: Myopia; Dry Eye Syndrome

Treatments: Device: Nelfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614600

A00849

Details and patient eligibility

About

The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
• Identified as symptomatic using a baseline screening questionnaire.
• Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
• Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
• Willing and able to follow instructions and maintain the appointment schedule.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Neophytes and current wearers of daily disposable contact lenses.
• Requires monovision correction.
• Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
• A history of ocular surgery/trauma within the last 6 months.
• Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

DAILIES® AquaComfort Plus®

Experimental group

Description:

Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks

Treatment:

Device: Nelfilcon A contact lenses