Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Keratoconus Clinical Trial

Official title:

Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01416272
• Other study ID #: ROC2-11-024
• Status: Terminated
• Phase: N/A
• First received: August 11, 2011
• Last updated: November 18, 2014
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2014
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• KeraSoft IC Soft Contact Lenses
Lenses will be worn between 8 and 16 hrs each day, for 12 months

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Symptoms and complaints measured on an analog scale	4 visits over 1 year	No
Secondary	Visual Acuity - Low Contrast	Low contrast visual acuity measured with high ambient illumination (LCHI)	4 visits over 1 year	No
Secondary	Visual Acuity - High Contrast	High contrast visual acuity measured with high ambient illumination (HCHI)	4 visits over 1 year	No