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Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

This study has been terminated.
(Study was terminated due to a business decision to cancel the entire project.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416272
First Posted: August 15, 2011
Last Update Posted: November 25, 2014
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):
Bausch & Lomb Incorporated
  Purpose
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 Intervention
Keratoconus Device: KeraSoft IC Soft Contact Lenses

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

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


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

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


Enrollment: 12
Study Start Date: April 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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:   18 Years and older   (Adult, Senior)
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
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
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Robert Steffen, OD, MS Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01416272     History of Changes
Other Study ID Numbers: ROC2-11-024
First Submitted: August 11, 2011
First Posted: August 15, 2011
Results First Submitted: November 18, 2014
Results First Posted: November 25, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases