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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lens; Device: Etafilcon A contact lens

• Registration Number: NCT01362907
• Lead Sponsor: CIBA VISION

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-27
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Posted: 2011-06-01
• Status Verified: 2012-06
• Results First Submitted: 2012-06-28
• Results First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Results First Posted: 2012-08-03
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Etafilcon A / delefilcon A	Delefilcon A contact lens	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.
Etafilcon A / delefilcon A	Etafilcon A contact lens	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.
Delefilcon A / etafilcon A	Delefilcon A contact lens	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.
Delefilcon A / etafilcon A	Etafilcon A contact lens	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.

Primary Outcome Measures

Name	Time	Method
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)	1 week of wear, replacing lenses daily	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.
Overall Vision Quality	1 week of wear, replacing lenses daily	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.
Overall Comfort	1 week of wear, replacing lenses daily	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.
Overall Handling	1 week of wear, replacing lenses daily	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.

Secondary Outcome Measures

Name	Time	Method
Overall Lens Fit	1 week of wear, replacing lenses daily	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.