Prospective Study of an Investigational Daily Disposable Contact Lens

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: delefilcon A contact lens; Device: narafilcon B contact lens

• Study Type: Interventional
• Enrollment (Actual): 90
• 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: delefilcon A; Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Device: delefilcon A contact lens; Investigational silicone hydrogel, single vision soft contact lens
Active Comparator: narafilcon B; Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Device: narafilcon B contact lens; Commercially marketed silicone hydrogel, single vision soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity	Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.	3 months of wear, lenses replaced daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Vision	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	3 months of wear, lenses replaced daily
Overall Comfort	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	3 months of wear, lenses replaced daily
Overall Handling	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	3 months of wear, lenses replaced daily

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-347-C-004