Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00810511
First received: December 17, 2008
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.


Condition Intervention
Myopia
Device: Lotrafilcon A contact lens
Device: Comfilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Comfort at End of Day [ Time Frame: After 4 weeks of wear ] [ Designated as safety issue: No ]
    Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 213
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon A
Investigational, spherical, silicone hydrogel contact lenses
Device: Lotrafilcon A contact lens
Silicone hydrogel contact lens
Active Comparator: Comfilcon A
Commercially marketed, spherical, silicone hydrogel contact lenses
Device: Comfilcon A contact lens
Silicone hydrogel contact lens

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
  • Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
  • Replace lenses on a weekly or longer schedule
  • Other protocol inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Requires concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrollment
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
  • Current soft toric lens wearers
  • Those who dispose of their soft lenses on a daily basis
  • Current NIGHT & DAY® or Biofinity® lens wearers
  • Other protocol-defined 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: NCT00810511     History of Changes
Other Study ID Numbers: P-335-C-007
Study First Received: December 17, 2008
Results First Received: July 23, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014