Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01416272
First received: August 11, 2011
Last updated: March 11, 2013
Last verified: March 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Symptoms and complaints measured on an analog scale


Secondary Outcome Measures:
  • Visual Acuity - low contrast [ Time Frame: 4 visits over 1 year ] [ Designated as safety issue: No ]
    Low contrast visual acuity measured with high ambient illumination (LCHI)

  • Visual Acuity - High Contrast [ Time Frame: 4 visits over 1 year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416272

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Stephanie Su, OD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01416272     History of Changes
Other Study ID Numbers: ROC2-11-024
Study First Received: August 11, 2011
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014