Prospective Study of an Investigational Toric Soft Contact Lens

Ciba Vision

Status: Completed

Conditions: Myopia; Refractive Error; Astigmatism

Treatments: Device: Nelfilcon A toric contact lenses (with comfort additives); Device: Nelfilcon A toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461811

C-11-035 (P-415-C-003)

Details and patient eligibility

About

The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.

Full description

Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.

Enrollment: 154 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
• Normal eyes not using any ocular medications that would contraindicate lens wear.
• Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
• Spectacle cylinder prescription between 0.50 and 2.00 diopters.
• Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Anterior segment infection, inflammation, or abnormality.
• Any active anterior segment or systemic disease that would contraindicate contact lens wear.
• Use of systemic medications that would contraindicate lens wear.
• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
• History of herpetic keratitis.
• History of refractive surgery or irregular cornea.
• History of pathologically dry eye.
• Corneal vascularization greater than 1 mm of penetration.
• Eye injury within twelve weeks immediately prior to enrollment in this trial.
• Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

DAILIES® AquaComfort Plus® Toric

Experimental group

Description:

Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months

Treatment:

Device: Nelfilcon A toric contact lenses (with comfort additives)

Focus® DAILIES® Toric

Active Comparator group

Description:

Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months

Treatment:

Device: Nelfilcon A toric contact lenses