Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric

Refractive Error Clinical Trial

Official title:

Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289742
• Other study ID #: M-14-010
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: May 12, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: March 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 the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must sign an informed consent document;

• Adapted, current soft contact lens wearer;

• Contact lens prescription in the power range specified in the protocol;

• Vision correctable to 0.2 (logMAR) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;

• Willing to wear study lenses up to 12 hours and attend all study visits;

• Can be successfully fitted with study lenses;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;

• 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 the Visit 1 slit-lamp examination;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Pregnant or lactating;

• Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;

• Participation in any clinical study within 30 days of Visit 1;

• Other protocol-specified exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A multifocal contact lenses

• Nelfilcon A toric contact lenses

• Nelfilcon A sphere contact lenses

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface wettability grading after 12 hours of wear	The investigator will take a video of the tear film and grade contact lens wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions).	Hour 12	No
Secondary	Surface wettability grading after 8 hours of wear	The investigator will take a video of the tear film and grade contact lens wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions).	Hour 8	No