Lotrafilcon B Multifocal Evaluations - Comparison to a Traditional Multifocal in Higher Spectacle Adds

CIBA VISION0 sites48 target enrollmentApril 2009

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: CIBA VISION
Enrollment: 48
Primary Endpoint: Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

May 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

CIBA VISION

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be at least 35 years of age.
•Best-corrected visual acuity of at least 20/40 in each eye.
•Spectacle add from +1.50D and +2.50D (inclusive).
•Able to be fit in available study sphere powers (Plano to -4.00D).
•Currently wearing soft contact lenses at least 5 days a week.
•Other protocol inclusion / exclusion criteria may apply.

Exclusion Criteria

•Requires concurrent ocular medication.
•Eye injury or surgery within twelve weeks immediately prior to enrollment.
•Currently enrolled in an ophthalmic clinical trial.
•Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
•Previous refractive surgery.
•Astigmatism \> 1.00D.
•Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
•Other protocol inclusion / exclusion criteria may apply.

Outcomes

Primary Outcomes

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity

Time Frame: After 1 week of wear

Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.