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

Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Farnham, Surrey, United Kingdom, GU9 7EN
      • Visioncare Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nelfilcon A/UltraFilcon B; Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.	Device: Nelfilcon A contact lens; Soft contact lens CE-marked for daily disposable wear.; Other Names: DAILIES® AquaComfort Plus®; Device: UltraFilcon B contact lens; Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.; Other Names: Procornea BYO Air Daily
Other: UltraFilcon B/Nelfilcon A; UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.	Device: Nelfilcon A contact lens; Soft contact lens CE-marked for daily disposable wear.; Other Names: DAILIES® AquaComfort Plus®; Device: UltraFilcon B contact lens; Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.; Other Names: Procornea BYO Air Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial comfort	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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Day Comfort	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).	Day 7
Overall Comfort	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).	Day 7
Overall Handling at Time of Removal	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).	Day 7

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Joachim Nick, Dipl. Ing., Alcon Research

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 4, 2013
• First Submitted That Met QC Criteria: August 4, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: contact lenses; daily disposable contact lenses; contact lens comfort; silicone hydrogel; near-sighted
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: C-13-033