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

Refractive Error Clinical Trial

Official title:

Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089191
• Other study ID #: M-14-006
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: April 30, 2015
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• 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;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A contact lenses

• Stenfilcon A contact lenses

Locations

Country	Name	City	State
Germany	Alcon Investigative Site	Jena

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Speed of Tear Film Break-up at 15 Seconds Post-blink 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 slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.	Hour 12	No