Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Delefilcon A contact lens; Device: Etafilcon A contact lens

• Study Type: Interventional
• Enrollment (Actual): 40
• 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:

• Normal eyes with no use of 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 protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
• Visual acuity with study lenses 20/25 or better.
• Cylinder less than or equal to 0.75 D.
• Currently wearing daily disposable lenses.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment infection, inflammation, or abnormality.
• 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.
• Eye injury within twelve weeks immediately prior to enrollment for this trial.
• Currently enrolled in any clinical trial.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Delefilcon A / etafilcon A; Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: Delefilcon A contact lens; Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear; Other Names: DAILIES® Total1®; Device: Etafilcon A contact lens; Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear; Other Names: 1-DAY ACUVUE® MOIST™
Other: Etafilcon A / delefilcon A; Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: Delefilcon A contact lens; Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear; Other Names: DAILIES® Total1®; Device: Etafilcon A contact lens; Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear; Other Names: 1-DAY ACUVUE® MOIST™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)	As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.	1 week of wear, replacing lenses daily
Overall Comfort	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week of wear, replacing lenses daily
Overall Vision Quality	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week of wear, replacing lenses daily
Overall Handling	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.	1 week of wear, replacing lenses daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Lens Fit	As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.	1 week of wear, replacing lenses daily

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): June 1, 2011

Study Record Updates

• Last Update Posted (Estimate): August 3, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 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-013