Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Myopia Clinical Trial

Official title:

Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371539
• Other study ID #: P-319-C-021
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 28, 2012
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: June 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 study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• At least 35 years of age.

• Spectacle add of +0.50 to +2.50 diopters (inclusive).

• Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.

• Able to be fit in both eyes with soft multifocal lenses in available powers.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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

• Currently enrolled in any clinical trial.

• Astigmatism of 1.00 diopter or more.

• Currently wearing excluded brands of multifocal lenses, as specified by protocol.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Presbyopia

Intervention

Device:
• Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
• Comfilcon A contact lens
Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity	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 equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.	1 week	No
Primary	Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity	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 equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.	1 week	No