N/A Completed N=64 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT02388763 ↗

Enrolled (actual)

Serious AEs

0.8%

Results posted

Oct 2016

Primary outcomePrimary: High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 — 0.453; 0.341 VA unit

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10	0.453; 0.341	—
SECONDARY High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10	0.614; 0.700	—

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02388763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.