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Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

NCT ID: NCT01416272

Last Updated: 2014-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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KeraSoft IC Soft Contact Lenses

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

Group Type EXPERIMENTAL

KeraSoft IC Soft Contact Lenses

Intervention Type DEVICE

Lenses will be worn between 8 and 16 hrs each day, for 12 months

Interventions

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KeraSoft IC Soft Contact Lenses

Lenses will be worn between 8 and 16 hrs each day, for 12 months

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Steffen, OD, MS

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb Incorporated

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ROC2-11-024

Identifier Type: -

Identifier Source: org_study_id