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

NCT02289742 | Completed Results

• 1 other identifier: M-14-010
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

Dailies AquaComfort Plus® Multifocal (DACP MF); Dailies AquaComfort Plus® Toric (DACP Toric); tear film stability; Non-Invasive Keratograph Break-Up Time (NIK-BUT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear

  Hour 8, each product

Study Arms (2)

Arm1: Presbyopes

OTHER

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; Device: Nelfilcon A sphere contact lenses

Arm2: Astigmats

OTHER

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; Device: Nelfilcon A sphere contact lenses

Interventions

Nelfilcon A multifocal contact lenses DEVICE

Also known as: DAILIES® AquaComfort Plus® Multifocal, DACP MF

Arm1: Presbyopes

Nelfilcon A toric contact lenses DEVICE

Also known as: DAILIES® AquaComfort Plus® Toric, DACP Toric

Arm2: Astigmats

Nelfilcon A sphere contact lenses DEVICE

Also known as: DAILIES® AquaComfort Plus®, DACP

Arm1: Presbyopes; Arm2: Astigmats

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must sign an informed consent document;
• Adapted, current soft contact lens wearer with either:
• A spectacle add between +0.50 and +2.50 (inclusive) \[Presbyopes group\]
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

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

• Sr. Clinical Manager, Global Med Affairs, Operations

  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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 26, 2016
• Results First Posted: July 26, 2016

Record last verified: 2016-06