Daily Disposable Contact Lens Tear Film Study

Ciba Vision

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01473160

P-347-C-014v2

Details and patient eligibility

About

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age of consent and sign Informed Consent document.
• Willing and able to wear spherical contact lenses for 16 hours.
• Willing and able to wear spherical contact lenses within the available range of powers.
• Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Anterior segment infection, inflammation, or abnormality.
• Any use of systemic medications for which contact lens wear could be contraindicated.
• History of refractive surgery or irregular cornea.
• Currently enrolled in any clinical trial.
• Eye injury within twelve weeks prior to enrollment.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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9 participants in 2 patient groups

delefilcon A

Experimental group

Description:

Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Treatment:

Device: delefilcon A contact lens

narafilcon A

Active Comparator group

Description:

Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Treatment:

Device: narafilcon A contact lens