ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

Alcon logo

Alcon

Status

Completed

Conditions

Refractive Error

Treatments

Device: Senofilcon A contact lenses
Device: Delefilcon A contact lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT02750813
CLV771-P001

Details and patient eligibility

About

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must sign informed consent form;
  • Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
  • Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
  • Cylinder equal or lower than -0.75D in both eyes;
  • Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
  • Can be successfully fitted with both study lenses at Visit 1;
  • Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Fitted with monovision;
  • Prior refractive surgery;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Pregnant or lactating;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Participation in any clinical study within 30 days of Visit 1;
  • Current DT1 or AO1D lens wearer;
  • Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

252 participants in 2 patient groups

DT1, then AO1D
Other group
Description:
Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
Treatment:
Device: Delefilcon A contact lenses
Device: Senofilcon A contact lenses
AO1D, then DT1
Other group
Description:
Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Treatment:
Device: Delefilcon A contact lenses
Device: Senofilcon A contact lenses

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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