Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

Presbyopia Clinical Trial

Official title:

Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268501
• Other study ID #: P-319-C-019
• Status: Completed
• Phase: N/A
• First received: December 29, 2010
• Last updated: June 26, 2012
• Start date: December 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• 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 trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 48 Years

Eligibility

Inclusion Criteria:

• Is between 40 and 48 years of age (inclusive).

• Has read and signed the Informed Consent.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Wears reading spectacles for close work.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.

• Currently enrolled in a clinical trial.

• Has worn contact lenses previously.

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lotrafilcon B multifocal contact lens
Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Convenience With Contact Lenses	Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."	3 weeks of wear	No