Clinical Evaluation of an Investigational Soft Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lens; Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX); Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus); Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

• Registration Number: NCT01254747
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-07
• Status Verified: 2012-04
• Results First Submitted: 2012-04-18
• Results First Submitted QC: 2012-04-18
• Results First Posted: 2012-05-17
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Germany: Be of legal age.
• USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
• Sign Informed Consent.
• Wear soft contact lenses for at least 3 months prior to the study.
• Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Regularly wear contact lenses on an extended/overnight basis.
• Germany: pregnant or lactating.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delefilcon A	Delefilcon A contact lens	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Lotrafilcon B	Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Nelfilcon A	Nelfilcon A contact lens (DAILIES AquaComfort Plus)	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Narafilcon A	Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Primary Outcome Measures

Name	Time	Method
Overall Comfort	4 weeks	Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Vision Quality During the Day	4 weeks	Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling	4 weeks	Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Dryness Throughout the Day	4 weeks	Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Average Daily Wear Time	4 weeks	Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.

Secondary Outcome Measures

Name	Time	Method
Lens Fit	4 weeks	Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
Corrected Visual Acuity	4 weeks	Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Overall Satisfaction	4 weeks	Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.

Trial Locations

Locations (1)

CIBA VISION Research Clinic; 🇩🇪 Grosswallstadt, Germany