Clinical Validation of the New Print on Focus DAILIES Toric

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: nelfilcon A contact lens, modified inversion indicator; Device: nelfilcon A contact lens, no inversion indicator; Device: nelfilcon A contact lens, inversion indicator

• Registration Number: NCT01097863
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-02
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-05-27
• Results First Submitted QC: 2011-05-27
• Results First Posted: 2011-06-27
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nelfilcon A, modified inversion indicator	nelfilcon A contact lens, modified inversion indicator	Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
nelfilcon A, no inversion indicator	nelfilcon A contact lens, no inversion indicator	Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
nelfilcon A, inversion indicator	nelfilcon A contact lens, inversion indicator	Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.

Primary Outcome Measures

Name	Time	Method
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.	1 week	As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.