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Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

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Alcon

Status

Completed

Conditions

Myopia
Refractive Error

Treatments

Device: Ultrafilcon B contact lens
Device: Stenfilcon A contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01898260
C-13-032

Details and patient eligibility

About

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

Enrollment

89 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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, understood and signed 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.

Trial design

89 participants in 2 patient groups

BYO Daily, then MyDay
Other group
Description:
Ultrafilcon B contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.
Treatment:
Device: Stenfilcon A contact lens
Device: Ultrafilcon B contact lens
MyDay, then BYO Daily
Other group
Description:
Stenfilcon A contact lenses, followed by ultrafilcon B contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.
Treatment:
Device: Stenfilcon A contact lens
Device: Ultrafilcon B contact lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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