Daily Wear Corneal Infiltrative Event Study

NCT ID: NCT00937105

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-02-29

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.

Conditions

Myopia; Hyperopia; Corneal Infiltrative Events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ReNu Multiplus and lotrafilcon A lenses

ReNu Multiplus contact lens care solution

Group Type: ACTIVE_COMPARATOR

lotrafilcon A contact lenses

Intervention Type: DEVICE

FDA approved soft contact lenses

Renu Multiplus

Intervention Type: DEVICE

Clear Care solution and lotrafilcon A lenses

Clear Care Contact Lens Care Solution

Group Type: ACTIVE_COMPARATOR

lotrafilcon A contact lenses

Intervention Type: DEVICE

FDA approved soft contact lenses

Clear Care

Intervention Type: DEVICE

Interventions

lotrafilcon A contact lenses

FDA approved soft contact lenses

Intervention Type: DEVICE

Renu Multiplus

Intervention Type: DEVICE

Clear Care

Intervention Type: DEVICE

Other Intervention Names

Air Optix Night & Day Aqua contact lenses

Eligibility Criteria

Inclusion Criteria

1. The patient must be at least 15 years old.

2. The patient must be free of any anterior segment disorders.

3. 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.

4. The patient must be correctable to 20/25 or better with spectacles.

5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.

6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria

1. The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. The patient is pregnant.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Loretta Szczotka-Flynn

OD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Loretta Szczotka-Flynn, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

Department of Ophthalmology University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24240354 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24756119 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id