Prospective Study of an Investigational Daily Disposable Contact Lens

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: delefilcon A contact lens; Device: narafilcon B contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295905

P-347-C-004

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.

Enrollment: 90 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with normal eyes who are not using any ocular medications.
• Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
• Willing and able to wear spherical contact lenses for at least 5 days per week.
• Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
• Best spectacle-corrected visual acuity greater than or equal to 20/25.
• Manifest cylinder less than or equal to 0.75D.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any active anterior segment ocular disease that would contraindicate contact lens wear.
• Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of refractive surgery or irregular cornea.
• History of pathologically dry eye.
• Eye injury within twelve weeks immediately prior to enrollment for this trial.
• Currently enrolled in any clinical trial.
• Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
• 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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90 participants in 2 patient groups

delefilcon A

Experimental group

Description:

Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.

Treatment:

Device: delefilcon A contact lens

narafilcon B

Active Comparator group

Description:

Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.

Treatment:

Device: narafilcon B contact lens