N/A N=80 Randomized Single-blind Treatment

Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

Astigmatism

Bottom Line

View on ClinicalTrials.gov: NCT02071771 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 — 0.02; 0.04 VA units

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nelfilcon A toric contact lenses (Device); Etafilcon A toric contact lenses (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY High Contrast Time Controlled Visual Acuity (TCVA) at Day 10	0.02; 0.04	—
SECONDARY Lens Oscillation at Blink at Day 10	2.1; 2.7; 2.1; 2.5	—

Summary

The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).

Eligibility Criteria

Inclusion Criteria

Must sign an Informed Consent document;
Wear toric soft contact lenses within the protocol-specified range;
Cylinder equal or higher than -0.75 diopters (D) in both eyes;
Have an acceptable fit with both study contact lenses;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
Best corrected visual acuity (BCVA) of 20/30 Snellen;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Require presbyopic correction;
Any ocular condition observed during examination at the enrollment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;
Pregnant or lactating;
Participation in any clinical trial within 30 days of the enrollment visit;
Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
Other protocol-specified exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02071771). 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.