Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Not Applicable

Terminated

• Conditions: Keratoconus
• Interventions: Device: KeraSoft IC Soft Contact Lenses

• Registration Number: NCT01416272
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-15
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2014-11
• Results First Submitted: 2014-11-18
• Results First Submitted QC: 2014-11-18
• Last Update Submitted: 2014-11-18
• Results First Posted: 2014-11-25
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Comfort	4 visits over 1 year	Symptoms and complaints measured on an analog scale

Secondary Outcome Measures

Name	Time	Method
Visual Acuity - Low Contrast	4 visits over 1 year	Low contrast visual acuity measured with high ambient illumination (LCHI)
Visual Acuity - High Contrast	4 visits over 1 year	High contrast visual acuity measured with high ambient illumination (HCHI)

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States