Clinical Validation of the New Print on Focus DAILIES Toric

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: nelfilcon A contact lens, modified inversion indicator; Device: nelfilcon A contact lens, no inversion indicator; Device: nelfilcon A contact lens, 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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nelfilcon A, modified inversion indicator; Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week	Device: nelfilcon A contact lens, modified inversion indicator; Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
Experimental: nelfilcon A, no inversion indicator; Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week	Device: nelfilcon A contact lens, no inversion indicator; Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
Active Comparator: nelfilcon A, inversion indicator; Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.	Device: nelfilcon A contact lens, inversion indicator; Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator; Other Names: Focus DAILIES Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.	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.	1 week

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-346-C-010