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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014