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

Presbyopia Clinical Trial

Official title:

DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235831
• Other study ID #: CLT330-P001
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: December 14, 2015
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: December 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® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Description:

In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• 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

• Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A MF contact lenses (DACP MF)
Multifocal contact lenses in Low, Medium, High Add
• Nelfilcon A single vision contact lenses (DACP)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (monte-carlo) 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). The AUC was calculated via the trapezoidal rule. A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.	Day 5, each product	No