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

NCT02235831 | Completed Results

• 1 other identifier: CLT330-P001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Conditions

Presbyopia; Refractive Error

Keywords

DACP MF; DAILIES AquaComfort Plus® Multifocal; presbyopia; visual performance

Outcome Measures

Primary Outcomes (1)

• Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance

  Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.

  Day 5, each product

Study Arms (3)

DACP MF

EXPERIMENTAL

DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).

Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP)

DACP

ACTIVE COMPARATOR

DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).

Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP)

DACP MF (Low Add)

ACTIVE COMPARATOR

DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).

Device: Nelfilcon A MF contact lenses (DACP MF); Device: Nelfilcon A single vision contact lenses (DACP)

Interventions

Nelfilcon A MF contact lenses (DACP MF) DEVICE

Multifocal contact lenses in Low, Medium, High Add

DACP; DACP MF; DACP MF (Low Add)

Nelfilcon A single vision contact lenses (DACP) DEVICE

DACP; DACP MF; DACP MF (Low Add)

Eligibility Criteria

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

You may qualify if:

• History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
• Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
• Requiring lenses within the power range of both study contact lenses to be fitted
• Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
• Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
• Acceptable fit with both study contact lenses
• Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible

You may not qualify if:

• Current multifocal contact lens wearer
• Current monovision wearer or failed attempt with monovision
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
• Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
• Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
• Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
• History of herpetic keratitis, ocular surgery or irregular cornea
• Prior refractive surgery (e.g. LASIK, PRK, etc)
• Monocular (only 1 eye with functional vision) or fit with only 1 lens
• Habitually uncorrected anisometropia \>2.00D
• Clinically significant anisocoria
• Participation in any clinical trial within 30 days of the enrollment visit

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Global Brand Lead, GCRA, Vision Care
• Organization: Alcon Research, Ltd.

1-888-451-3937

Study Officials

• Clinical Manager, EMEA

  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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 11, 2016
• Results First Posted: January 18, 2016

Record last verified: 2016-06