Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

Alcon

Status: Completed

Conditions: Astigmatism

Treatments: Device: Nelfilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02071771

M-14-007

Details and patient eligibility

About

The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign an Informed Consent document;
• Wear toric soft contact lenses within the protocol-specified range;
• Cylinder equal or higher than -0.75 diopters (D) in both eyes;
• Have an acceptable fit with both study contact lenses;
• Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
• Best corrected visual acuity (BCVA) of 20/30 Snellen;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Require presbyopic correction;
• Any ocular condition observed during examination at the enrollment visit;
• History of herpetic keratitis, ocular surgery or irregular cornea;
• Pregnant or lactating;
• Participation in any clinical trial within 30 days of the enrollment visit;
• Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

DACP T, Then 1DAM A

Other group

Description:

Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.

Treatment:

Device: Etafilcon A toric contact lenses

Device: Nelfilcon A toric contact lenses

1DAM A, Then DACP T

Other group

Description:

Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.

Treatment:

Device: Etafilcon A toric contact lenses

Device: Nelfilcon A toric contact lenses