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

Not Applicable

Completed

• Conditions: Refractive Error

• Registration Number: NCT02289742
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-13
• Study Start: 2014-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-03-31
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-15
• Results First Posted: 2016-07-26
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear	Hour 12, each product	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear	Hour 8, each product	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.