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Completed

NCT Number: NCT01917162

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

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

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visioncare Research Ltd

Farnham, Surrey, GU9 7EN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfilcon A contact lens

Device

Soft contact lens CE-marked for daily disposable wear.

Other names: DAILIES® AquaComfort Plus®

Ultrafilcon B contact lens

Device

Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Other names: Procornea BYO Air Daily

Primary outcomes

  1. Initial comfort

    Time frame: 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 outcomes

  1. End of Day Comfort

    Time frame: 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).

  2. Overall Comfort

    Time frame: 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).

  3. Overall Handling at Time of Removal

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2013
Registry last updated
Nov 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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