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

Refractive Error Clinical Trial

Official title:

Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388763
• Other study ID #: CLY838-P001
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: September 25, 2015
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

After randomization, participants will attend a baseline visit to include a 3 hour exposure to reduced humidity environment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• Other protocol-specified inclusion criteria may apply.

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.

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Stenfilcon A contact lenses

• Narafilcon A contact lenses

Locations

Country	Name	City	State
United Kingdom	Alcon Investigative Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High contrast TCVA, reduced humidity	High contrast TCVA will be assessed after 3 hours exposure to reduced humidity environment.	Day 10	No
Secondary	High contrast TCVA, normal environment	High contrast TCVA will be assessed after 3 hours exposure to normal environment.	Day 10	No