DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance-PART 2

Presbyopia Clinical Trial

Official title:

Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® MF and PROCLEAR 1 Day MF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403180
• Other study ID #: CLW681-P001
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: July 21, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Multifocal and PROCLEAR® 1 Day Multifocal daily disposable contact lenses in an established presbyopic population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must sign an informed consent;

• Adapted soft contact lens wearer;

• Vision correctable to 20/30 (0.2 logMAR) 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;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Current multifocal contact lens wearer;

• 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 (e.g. LASIK, PRK, etc);

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• Other protocol-specified exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Nelfilcon A Contact Lenses

• Omafilcon A 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	Stereopsis acuity at near	Stereoacuity will be determined with the Howard-Dolman system. A fixed rod will be located at 40 cm from the eye and interpupillary distance will be measured.	Day 5	No
Secondary	Area under the mean defocus curve	Area of focus will be calculated from the defocus curve at high luminance. This outcome measure is prespecified after 5±1 days of wearing for DACP MF and PROCLEAR® 1 Day Multifocal.	Day 5	No