Clinical Validation of the New Print on Focus DAILIES Toric

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: nelfilcon A contact lens, modified inversion indicator; Device: nelfilcon A contact lens, no inversion indicator; Device: nelfilcon A contact lens, inversion indicator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097863

P-346-C-010

Details and patient eligibility

About

The purpose of this study is to validate the improvements to the inversion indicator.

Full description

This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

Enrollment: 280 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
• Willing and able to wear study lenses in both eyes in the available parameters.
• Light-eyed subjects.
• Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
• Optimal or acceptable fit in each eye at time of dispensing.
• Willing to wear the study lenses at least 8 hours a day, 5 days a week.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks prior to enrollment for this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• RGP contact lens wearer.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 3 patient groups

nelfilcon A, modified inversion indicator

Experimental group

Description:

Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

Treatment:

Device: nelfilcon A contact lens, modified inversion indicator

nelfilcon A, no inversion indicator

Experimental group

Description:

Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

Treatment:

Device: nelfilcon A contact lens, no inversion indicator

nelfilcon A, inversion indicator

Active Comparator group

Description:

Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.

Treatment:

Device: nelfilcon A contact lens, inversion indicator