Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01007812
First received: November 2, 2009
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.


Condition Intervention
Astigmatism
Device: Lotrafilcon B contact lens
Device: Comfilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Vision [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
    Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lotrafilcon B / Comfilcon A
Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.
Device: Lotrafilcon B contact lens
Silicone hydrogel, toric, soft contact lens
Device: Comfilcon A contact lens
Silicone hydrogel, toric, soft contact lens
Comfilcon A / Lotrafilcon B
Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.
Device: Lotrafilcon B contact lens
Silicone hydrogel, toric, soft contact lens
Device: Comfilcon A contact lens
Silicone hydrogel, toric, soft contact lens

  Eligibility

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

Inclusion Criteria:

  • Have a current spectacle prescription, preferably within 6-9 months.
  • Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
  • Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
  • Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • Currently enrolled in any Clinical Trial.
  • Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Currently wearing soft toric contact lenses as extended wear.
  • Currently wearing either of the products to be worn in the study.
  • 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: NCT01007812     History of Changes
Other Study ID Numbers: P-242-C-032
Study First Received: November 2, 2009
Results First Received: September 29, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014