Daily Wear Corneal Infiltrative Event Study

NCT00937105 | Completed Phase 4 Results DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 1 year

Secondary Outcomes (5)

• Number of Participants With CIE Stratified by Microbial Bioburden on Lenses

  up to 1 year

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

  up to 1 year

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

  up to 1 year

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

  up to 1 year

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

  up to 1 year

Study Arms (2)

ReNu Multiplus and lotrafilcon A lenses

ACTIVE COMPARATOR

ReNu Multiplus contact lens care solution

Device: lotrafilcon A contact lenses; Device: Renu Multiplus

Clear Care solution and lotrafilcon A lenses

ACTIVE COMPARATOR

Clear Care Contact Lens Care Solution

Device: lotrafilcon A contact lenses; Device: Clear Care

Interventions

lotrafilcon A contact lenses DEVICE

FDA approved soft contact lenses

Also known as: Air Optix Night & Day Aqua contact lenses

Clear Care solution and lotrafilcon A lenses; ReNu Multiplus and lotrafilcon A lenses

Renu Multiplus DEVICE

ReNu Multiplus and lotrafilcon A lenses

Clear Care DEVICE

Clear Care solution and lotrafilcon A lenses

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Alcon Research: collaborator

Study Sites (1)

Department of Ophthalmology University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• 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.

  PMID: 24240354 RESULT

• 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.

  PMID: 24756119 DERIVED

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Mostly asymptomatic CIE events occurred which limited the ability to retrieve the lens worn (for culture) precisely at the time of CIE development; this may have hindered our ability to capture bioburden at the time of the adverse event.

Results Point of Contact

• Title: Loretta Szczotka-Flynn OD, PhD
• Organization: University Hospitals Eye Institute

loretta.szczotka@uhhospitals.org

216-844-3609

Study Officials

• Loretta Szczotka-Flynn, OD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OD, PhD

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 10, 2014
• Results First Posted: March 10, 2014

Record last verified: 2014-01

Locations

US (1)