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

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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Nelfilcon A toric contact lenses; Device: Nelfilcon A multifocal contact lenses; Device: Nelfilcon A sphere contact lenses

Detailed Description

Two population groups (presbyopes and astigmats) will be enrolled in the study.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign an informed consent document;

• Adapted, current soft contact lens wearer with either:

  1. A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]
  2. A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];
• Contact lens prescription in the power range specified in the protocol;
• Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm1: Presbyopes; Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.	Device: Nelfilcon A multifocal contact lenses; Other Names: DAILIES® AquaComfort Plus® Multifocal; DACP MF; Device: Nelfilcon A sphere contact lenses; Other Names: DAILIES® AquaComfort Plus®; DACP
Other: Arm2: Astigmats; Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.	Device: Nelfilcon A toric contact lenses; Other Names: DACP Toric; DAILIES® AquaComfort Plus® Toric; Device: Nelfilcon A sphere contact lenses; Other Names: DAILIES® AquaComfort Plus®; DACP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear	A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.	Hour 12, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear	A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.	Hour 8, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Manager, Global Med Affairs, Operations, Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: tear film stability; Dailies AquaComfort Plus® Multifocal (DACP MF); Dailies AquaComfort Plus® Toric (DACP Toric); Non-Invasive Keratograph Break-Up Time (NIK-BUT)
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: M-14-010