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

NCT ID: NCT02388763

Last Updated: 2016-12-05

Basic Information

• 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

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

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

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

MyDay™; 1-DAY ACUVUE® TruEye®

Eligibility Criteria

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

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Manager, EMEA

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Other Identifiers

CLY838-P001

Identifier Type: -

Identifier Source: org_study_id