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

NCT02071771 | Completed Results

• 1 other identifier: M-14-007
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Astigmatism

Keywords

DACP Toric; DAILIES® AquaComfort Plus®; Astigmatism; Toric

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Lens Oscillation at Blink at Day 10

  Day 10, each product

Study Arms (2)

DACP T, Then 1DAM A

OTHER

Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.

Device: Nelfilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

1DAM A, Then DACP T

OTHER

Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.

Device: Nelfilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

Interventions

Nelfilcon A toric contact lenses DEVICE

Also known as: DACP Toric, DAILIES® AQUACOMFORT PLUS® TORIC

1DAM A, Then DACP T; DACP T, Then 1DAM A

Etafilcon A toric contact lenses DEVICE

Also known as: 1-DAY ACUVUE® MOIST® for Astigmatism

1DAM A, Then DACP T; DACP T, Then 1DAM A

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sr Global Brand Lead, GCRA, Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, EMEA

  Alcon Research

  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: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 10, 2015
• Results First Posted: November 10, 2015

Record last verified: 2015-10