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Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

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.
 
ClinicalTrials.gov Identifier: NCT01416272
Recruitment Status : Terminated (Study was terminated due to a business decision to cancel the entire project.)
First Posted : August 15, 2011
Results First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.

Condition or disease Intervention/treatment Phase
Keratoconus Device: KeraSoft IC Soft Contact Lenses Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KeraSoft IC Soft Contact Lenses
KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
 Device: KeraSoft IC Soft Contact Lenses
Lenses will be worn between 8 and 16 hrs each day, for 12 months


Outcome Measures
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Primary Outcome Measures :
  1. Comfort [ Time Frame: 4 visits over 1 year ]
    Symptoms and complaints measured on an analog scale


Secondary Outcome Measures :
  1. Visual Acuity - Low Contrast [ Time Frame: 4 visits over 1 year ]
    Low contrast visual acuity measured with high ambient illumination (LCHI)

  2. Visual Acuity - High Contrast [ Time Frame: 4 visits over 1 year ]
    High contrast visual acuity measured with high ambient illumination (HCHI)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have participated and completed a previous study (ROC2-10-078).
  • Is Keratoconic

Exclusion Criteria:

  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Is not correctable to 20/50 or better in each eye with contact lenses.
  • Has greater than Grade 2 slit lamp exam findings.
  • Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
  • Has any neovascularization within the central 4mm of the cornea.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416272


Locations
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United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Robert Steffen, OD, MS Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01416272    
Other Study ID Numbers: ROC2-11-024
First Posted: August 15, 2011    Key Record Dates
Results First Posted: November 25, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases