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

NCT02388763 | Completed Results

• 1 other identifier: CLY838-P001
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (1)

• High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10

  High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

  Day 10, each product

Secondary Outcomes (1)

• High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10

  Day 10, each product

Study Arms (2)

MyDay, then 1DAVTE

OTHER

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.

Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses

1DAVTE, then MyDay

OTHER

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

Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses

Interventions

Stenfilcon A contact lenses DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Also known as: MyDay™

1DAVTE, then MyDay; MyDay, then 1DAVTE

Narafilcon A contact lenses DEVICE

Contact lenses worn during Period 1 or 2, as randomized

Also known as: 1-DAY ACUVUE® TruEye®

1DAVTE, then MyDay; MyDay, then 1DAVTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: GMA Franchise Head - Vision Care, GCRA
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Manager, EMEA

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 5, 2016
• Results First Posted: October 19, 2016

Record last verified: 2016-10