Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

November 18, 2014 updated by: Bausch & Lomb Incorporated
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch & Lomb Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: 4 visits over 1 year
Symptoms and complaints measured on an analog scale
4 visits over 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity - Low Contrast
Time Frame: 4 visits over 1 year
Low contrast visual acuity measured with high ambient illumination (LCHI)
4 visits over 1 year
Visual Acuity - High Contrast
Time Frame: 4 visits over 1 year
High contrast visual acuity measured with high ambient illumination (HCHI)
4 visits over 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 15, 2011

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROC2-11-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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