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

Astigmatism Clinical Trial

Official title:

DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071771
• Other study ID #: M-14-007
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: October 13, 2015
• Start date: April 2014
• Est. completion date: September 2014

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Nelfilcon A toric contact lenses

• Etafilcon A toric contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Contrast Time Controlled Visual Acuity (TCVA) at Day 10	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	No
Secondary	Lens Oscillation at Blink at Day 10	Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.	Day 10, each product	No