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Daily Wear Corneal Infiltrative Event Study (DWCIE)

Primary Purpose

Myopia, Hyperopia, Corneal Infiltrative Events

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

lotrafilcon A contact lenses

Renu Multiplus

Clear Care

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The patient must be at least 15 years old.
The patient must be free of any anterior segment disorders.
The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
The patient must be correctable to 20/25 or better with spectacles.
Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria

The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.
The patient is pregnant.

Sites / Locations

Department of Ophthalmology University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ReNu Multiplus and lotrafilcon A lenses

Clear Care solution and lotrafilcon A lenses

Arm Description

ReNu Multiplus contact lens care solution

Clear Care Contact Lens Care Solution

Outcomes

Primary Outcome Measures

Number of Participants Developing a Corneal Inflammatory Event (CIE)

Raw number of participants in each solution arm developing CIE over 12 month follow-up period

Secondary Outcome Measures

Number of Participants With CIE Stratified by Microbial Bioburden on Lenses

Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses

Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.

Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones

Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases

Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora

Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins

Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids

Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins

Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids

Full Information

NCT ID

NCT00937105

First Posted

July 9, 2009

Last Updated

January 27, 2014

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00937105

Brief Title

Daily Wear Corneal Infiltrative Event Study

Acronym

DWCIE

Official Title

Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night & Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Hyperopia, Corneal Infiltrative Events

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

218 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ReNu Multiplus and lotrafilcon A lenses

Arm Type

Active Comparator

Arm Description

ReNu Multiplus contact lens care solution

Arm Title

Clear Care solution and lotrafilcon A lenses

Arm Type

Active Comparator

Arm Description

Clear Care Contact Lens Care Solution

Intervention Type

Device

Intervention Name(s)

lotrafilcon A contact lenses

Other Intervention Name(s)

Air Optix Night & Day Aqua contact lenses

Intervention Description

FDA approved soft contact lenses

Intervention Type

Device

Intervention Name(s)

Renu Multiplus

Intervention Type

Device

Intervention Name(s)

Clear Care

Primary Outcome Measure Information:

Title

Number of Participants Developing a Corneal Inflammatory Event (CIE)

Description

Raw number of participants in each solution arm developing CIE over 12 month follow-up period

Time Frame

up to 1 year

Secondary Outcome Measure Information:

Title

Number of Participants With CIE Stratified by Microbial Bioburden on Lenses

Description

Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses

Time Frame

up to 1 year

Title

Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.

Description

Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones

Time Frame

up to 1 year

Title

Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases

Description

Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora

Time Frame

up to 1 year

Title

Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins

Description

Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids

Time Frame

up to 1 year

Title

Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins

Description

Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids

Time Frame

up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient must be at least 15 years old. The patient must be free of any anterior segment disorders. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder. The patient must be correctable to 20/25 or better with spectacles. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D. Can be successfully fit with lotrafilcon A lenses at the enrollment visit. Exclusion Criteria The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months. The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery. The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use. The patient is pregnant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Loretta Szczotka-Flynn, OD, PhD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Ophthalmology University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24240354

Citation

Szczotka-Flynn L, Jiang Y, Raghupathy S, Bielefeld RA, Garvey MT, Jacobs MR, Kern J, Debanne SM. Corneal inflammatory events with daily silicone hydrogel lens wear. Optom Vis Sci. 2014 Jan;91(1):3-12. doi: 10.1097/OPX.0000000000000105.

Results Reference

result

PubMed Identifier

24756119

Citation

Jiang Y, Jacobs M, Bajaksouzian S, Foster AN, Debanne SM, Bielefeld R, Garvey M, Raghupathy S, Kern J, Szczotka-Flynn LB. Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses. Eye Contact Lens. 2014 May;40(3):148-56. doi: 10.1097/ICL.0000000000000026.

Results Reference

derived

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Daily Wear Corneal Infiltrative Event Study

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