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
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: 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

ClinicalTrials.gov processed this record on September 18, 2014