Study Stopped
Study was terminated due to a business decision to cancel the entire project.
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
August 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
November 25, 2014
CompletedNovember 25, 2014
November 1, 2014
1.7 years
August 11, 2011
November 18, 2014
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Comfort
Symptoms and complaints measured on an analog scale
4 visits over 1 year
Secondary Outcomes (2)
Visual Acuity - Low Contrast
4 visits over 1 year
Visual Acuity - High Contrast
4 visits over 1 year
Study Arms (1)
KeraSoft IC Soft Contact Lenses
EXPERIMENTALKeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care
Interventions
Lenses will be worn between 8 and 16 hrs each day, for 12 months
Eligibility Criteria
You may qualify if:
- Have participated and completed a previous study (ROC2-10-078).
- Is Keratoconic
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb Incorporated
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Steffen, OD, MS
- Organization
- Bausch & Lomb / Valeant Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Robert Steffen, OD, MS
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2011
First Posted
August 15, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
November 25, 2014
Results First Posted
November 25, 2014
Record last verified: 2014-11