Two Daily Disposable Contact Lenses in Symptomatic Patients

Alcon logo

Alcon

Status

Completed

Conditions

Myopia

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03628599
CLS312-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Able to understand and must sign an IRB-approved informed consent form; * Soft contact lens wearers in both eyes during the past 3 months; * Best-corrected visual acuity (BCVA) 20/25 or better in each eye; * Willing to wear study lenses at least 3 days per week and at least 8 hours per day; * Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion criteria

* Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol; * Intolerance, hypersensitivity, or allergy to any component of the study products; * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Monocular (only one eye with functional vision).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

39 participants in 2 patient groups

TOTAL1
Experimental group
Description:
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
Treatment:
Device: Delefilcon A contact lenses
1-DAY
Active Comparator group
Description:
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Treatment:
Device: Senofilcon A contact lenses

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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