Prospective Study of an Investigational Daily Disposable Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: delefilcon A contact lens; Device: narafilcon B contact lens

• Registration Number: NCT01295905
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-15
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-04-18
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-18
• Results First Posted: 2012-06-20
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delefilcon A	delefilcon A contact lens	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
narafilcon B	narafilcon B contact lens	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.

Primary Outcome Measures

Name	Time	Method
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity	3 months of wear, lenses replaced daily	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.

Secondary Outcome Measures

Name	Time	Method
Overall Handling	3 months of wear, lenses replaced daily	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.
Overall Comfort	3 months of wear, lenses replaced daily	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.
Overall Vision	3 months of wear, lenses replaced daily	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.