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Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Primary Purpose

Keratoconus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KeraSoft IC Soft Contact Lenses
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KeraSoft IC Soft Contact Lenses

Arm Description

KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care

Outcomes

Primary Outcome Measures

Comfort
Symptoms and complaints measured on an analog scale

Secondary Outcome Measures

Visual Acuity - Low Contrast
Low contrast visual acuity measured with high ambient illumination (LCHI)
Visual Acuity - High Contrast
High contrast visual acuity measured with high ambient illumination (HCHI)

Full Information

First Posted
August 11, 2011
Last Updated
November 18, 2014
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01416272
Brief Title
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
Official Title
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to a business decision to cancel the entire project.
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KeraSoft IC Soft Contact Lenses
Arm Type
Experimental
Arm Description
KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
Intervention Type
Device
Intervention Name(s)
KeraSoft IC Soft Contact Lenses
Intervention Description
Lenses will be worn between 8 and 16 hrs each day, for 12 months
Primary Outcome Measure Information:
Title
Comfort
Description
Symptoms and complaints measured on an analog scale
Time Frame
4 visits over 1 year
Secondary Outcome Measure Information:
Title
Visual Acuity - Low Contrast
Description
Low contrast visual acuity measured with high ambient illumination (LCHI)
Time Frame
4 visits over 1 year
Title
Visual Acuity - High Contrast
Description
High contrast visual acuity measured with high ambient illumination (HCHI)
Time Frame
4 visits over 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Steffen, OD, MS
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

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