Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Presbyopia Clinical Trial

Official title:

Delefilcon A Multifocal Plus Power Lens Design Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951573
• Other study ID #: C-13-011
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: November 24, 2014
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with normal eyes who are not using any ocular medication.

• Must sign the Informed Consent document.

• Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).

• Manifest cylinder less than or equal to 0.75D.

• Best corrected distance VA greater than or equal to 20/25 in each eye.

• Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.

• Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular disease, inflammation, or abnormality that contraindicates CL wear.

• Any use of systemic or ocular medications for which CL wear could be contraindicated.

• History of herpetic keratitis.

• History of refractive surgery or irregular cornea.

• A clinically significant dry eye that precludes CL wear.

• Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.

• Monocular (only 1 eye with functional vision).

• History of intolerance or hypersensitivity to any component of the test articles.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia
• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A multifocal contact lenses
Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
• Lotrafilcon B multifocal contact lenses
Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near	Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.	Dispense (Day 1), Hour 9	No
Secondary	HC/HI Binocular VA at Distance	Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.	Dispense (Day 1), Hour 9	No
Secondary	Over-refraction (OR) Monocular at Distance	OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.	Dispense (Day 1), Hour 9	No