Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Bausch + Lomb

Status: Terminated

Conditions: Keratoconus

Treatments: Device: KeraSoft IC Soft Contact Lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416272

ROC2-11-024

Details and patient eligibility

About

The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

KeraSoft IC Soft Contact Lenses

Experimental group

Description:

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

Treatment:

Device: KeraSoft IC Soft Contact Lenses