DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

NCT02403180 | Completed Results

• 1 other identifier: CLW681-P001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.

Conditions

Presbyopia

Keywords

Visual Performance

Outcome Measures

Primary Outcomes (1)

• Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear

  Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.

  Day 5, each product

Secondary Outcomes (1)

• Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear

  Day 5, each product

Study Arms (2)

DACP MF, then PROCLEAR 1D MF

OTHER

DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.

Device: DACP MF; Device: PROCLEAR 1D MF

PROCLEAR 1D MF, then DACP MF

OTHER

PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.

Device: DACP MF; Device: PROCLEAR 1D MF

Interventions

DACP MF DEVICE

Nelfilcon A multifocal contact lenses

Also known as: DAILIES® AquaComfort Plus® Multifocal (DACP MF), Nelfilcon A

DACP MF, then PROCLEAR 1D MF; PROCLEAR 1D MF, then DACP MF

PROCLEAR 1D MF DEVICE

Omafilcon A multifocal contact lenses

Also known as: PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF), Omafilcon A

DACP MF, then PROCLEAR 1D MF; PROCLEAR 1D MF, then DACP MF

Eligibility Criteria

• Age: 41 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must sign an informed consent;
• Adapted soft contact lens wearer;
• Vision correctable to 20/30 \[(0.2 logMAR (logarithm of the minimum angle of resolution)\] or better in each eye at distance;
• Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;

You may not qualify if:

• Currently wearing multifocal contact lenses;
• Currently wearing monovision;
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications which could contraindicate contact lens wear;
• Eye injury or surgery within 12 weeks prior to enrollment;
• Prior refractive surgery;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Global Medical Affairs Franchise Head, Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager

  Alcon, Spain

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

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-07