Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens

• Registration Number: NCT01917162
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-08-04
• Study First Submitted QC: 2013-08-04
• Study First Posted: 2013-08-06
• Study Start: 2013-09
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Adapted soft contact lens wearer;
• Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
• Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
• Correctable to 6/9 (20/30) in both eyes;
• Read, understand, and sign the informed consent;
• Willing to comply with the wear schedule;
• Willing to comply with the study visit schedule;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Any active corneal infection, injury or inflammation;
• Systemic or ocular allergies which might interfere with contact lens wear;
• Systemic or ocular disease which might interfere with contact lens wear;
• Strabismus or amblyopia;
• Corneal refractive surgery and any anterior segment surgery;
• Use of systemic/topical medication contraindicating contact lens wear;
• Use of gas permeable contact lenses within 1 month preceding the study;
• Participation in any concurrent clinical trial or in the last 30 days;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nelfilcon A/UltraFilcon B	Nelfilcon A contact lens	Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Nelfilcon A/UltraFilcon B	UltraFilcon B contact lens	Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
UltraFilcon B/Nelfilcon A	Nelfilcon A contact lens	UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
UltraFilcon B/Nelfilcon A	UltraFilcon B contact lens	UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Initial comfort	Baseline	Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

Secondary Outcome Measures

Name	Time	Method
End of Day Comfort	Day 7	End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Overall Comfort	Day 7	Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Overall Handling at Time of Removal	Day 7	Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).

Trial Locations

Locations (1)

Visioncare Research Ltd; 🇬🇧 Farnham, Surrey, United Kingdom