A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Presbyopia Clinical Trial

Official title:

A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539694
• Other study ID #: 744E
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have physiologically normal anterior segments.

• Be adapted wearers of soft contact lenses and wear a lens in each eye.

• Be presbyopic and require near add correction in each eye.

• Have no active ocular disease or allergic conjunctivitis.

• Must not be using any topical ocular medications.

Exclusion Criteria:

• Any Grade 2 or greater finding during the slit lamp examination.

• Any scar or neovascularization within the central 4mm of the cornea.

• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Allergic to any component in the study products.

• Any systemic disease affecting ocular health.

• Using any systemic or topical medications that will affect ocular physiology or lens performance.

• An active ocular disease, any corneal infiltrative response or are using any ocular medications.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• LD118033 contact lens
Multifocal contact lens worn on a daily wear basis for 1 week
• PureVision multifocal contact lens
PureVision multifocal contact lens worn on a daily wear basis for 1 week.

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).	At 1 week follow up
Secondary	Symptoms/Complaints	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.	At 1 week follow up