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Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

NCT ID: NCT02388763

Last Updated: 2016-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

Detailed Description

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After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Conditions

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Refractive Error

Keywords

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Contact lenses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MyDay, then 1DAVTE

Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.

Group Type OTHER

Stenfilcon A contact lenses

Intervention Type DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Narafilcon A contact lenses

Intervention Type DEVICE

Contact lenses worn during Period 1 or 2, as randomized

1DAVTE, then MyDay

Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.

Group Type OTHER

Stenfilcon A contact lenses

Intervention Type DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Narafilcon A contact lenses

Intervention Type DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Interventions

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Stenfilcon A contact lenses

Contact lenses worn during Period 1 or 2, as randomized

Intervention Type DEVICE

Narafilcon A contact lenses

Contact lenses worn during Period 1 or 2, as randomized

Intervention Type DEVICE

Other Intervention Names

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MyDay™ 1-DAY ACUVUE® TruEye®

Eligibility Criteria

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Inclusion Criteria

* Must sign informed consent form.
* Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
* Willing to wear lenses every day or at least 5 days per week 6 hours per day.
* Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.

Exclusion Criteria

* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* Pregnant or lactating.
* Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
* Any abnormal ocular condition as specified in the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Manager, EMEA

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Countries

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United Kingdom United States

Other Identifiers

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CLY838-P001

Identifier Type: -

Identifier Source: org_study_id