Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

NCT02089191 | Completed Results

• 1 other identifier: M-14-006
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Conditions

Refractive Error

Keywords

DACP; DAILIES® AquaComfort Plus; Tear film stability; NIK-BUT

Outcome Measures

Primary Outcomes (1)

• Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear

  The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.

  Day 1, Hour 12, each period

Secondary Outcomes (1)

• Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear

  Hour 12

Study Arms (2)

DACP/MyDay

OTHER

Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses

MyDay/DACP

OTHER

Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses

Interventions

Nelfilcon A contact lenses DEVICE

Also known as: DAILIES® AquaComfort Plus®, DACP

DACP/MyDay; MyDay/DACP

Stenfilcon A contact lenses DEVICE

Also known as: MyDay®

DACP/MyDay; MyDay/DACP

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must sign an Informed Consent form;
• Adapted, current soft contact lens wearer;
• Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
• Cylinder ≤ -1.00 D in both eyes at Visit 1;
• Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
• Willing to wear study lenses up to 12 hours and attend all study visits;
• Able to be successfully fitted with study lenses;
• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;

You may not qualify if:

• Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Use of artificial tears and rewetting drops during the study;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Any abnormal ocular condition observed during Visit 1;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Participation in any clinical study within 30 days of Visit 1;
• Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Investigative Site

Jena, Germany

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

There was a high censoring rate observed with the objective measurements and therefore there are limitations to the conclusions that may be drawn.

Results Point of Contact

• Title: Global Medical Affairs Brand Lead - Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Global Medical Affairs, Clinical Manager, Vision Care

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 15, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-04

Locations

DE (1)