Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Presbyopia Clinical Trial

Official title:

Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909792
• Other study ID #: P-319-C-013
• Status: Completed
• Phase: N/A
• First received: May 27, 2009
• Last updated: June 26, 2012
• Start date: May 2009
• Est. completion date: June 2009

Study information

• Verified date: January 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 objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Be at least 35 years of age

• Best-corrected distance visual acuity of at least 20/40 in each eye.

• Spectacle add between +0.75D and +1.50D (inclusive).

• Able to be fit in available study sphere powers (-1.00 to -5.00D)

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

• Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

• 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.

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

• Astigmatism = 1.00D.

• Currently wearing either of the study products.

• Other protocol inclusion/exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens
• Senofilcon A
Silicone hydrogel, soft, multifocal contact lens

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	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.	After 1 week of wear	No