Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00909792
First received: May 27, 2009
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.


Condition Intervention
Presbyopia
Device: Lotrafilcon B
Device: Senofilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
    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.


Enrollment: 259
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lotrafilcon B / Senofilcon A
Lotrafilcon B, followed by Senofilcon A
Device: Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens
Device: Senofilcon A
Silicone hydrogel, soft, multifocal contact lens
Senofilcon A / Lotrafilcon B
Senofilcon A, followed by Lotrafilcon B
Device: Lotrafilcon B
Silicone hydrogel, soft, multifocal contact lens
Device: Senofilcon A
Silicone hydrogel, soft, multifocal contact lens

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00909792     History of Changes
Other Study ID Numbers: P-319-C-013
Study First Received: May 27, 2009
Results First Received: September 16, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014