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Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007812
First Posted: November 4, 2009
Last Update Posted: June 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  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 (Participant)
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 ( CIBA VISION ):

Primary Outcome Measures:
  • Overall Vision [ Time Frame: After 1 week of wear ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01007812     History of Changes
Other Study ID Numbers: P-242-C-032
First Submitted: November 2, 2009
First Posted: November 4, 2009
Results First Submitted: September 29, 2010
Results First Posted: November 17, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases