Multifocal Lens Design Evaluation

Presbyopia Clinical Trial

Official title:

Multifocal Lens Design Evaluation (US)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997216
• Other study ID #: C-12-036
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: December 17, 2013
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• 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 was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.

Description:

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign written Informed Consent document.

• Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.

• Be presbyopic with a spectacle add = 0.50 diopter.

• Currently wearing soft contact lenses at least 5 days a week.

• Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

• Eye injury or surgery within 12 weeks of enrollment in this trial.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in any clinical trial.

• Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.

• Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.

• Binocular visual acuity worse than 20/25.

• Corrected by monovision.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A multifocal contact lens
Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
• Lotrafilcon B multifocal contact lens
Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Binocular HC/HI Visual Acuity at Near (40 cm)	The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.	Up to Hour 9	No
Secondary	Mean Binocular HC/HI Visual Acuity at Distance	The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.	Up to Hour 9	No
Secondary	Mean Monocular Over-refraction (OR) at Distance	OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.	Up to Hour 9	No