Clinical trial NCT00937105: Daily Wear Corneal Infiltrative Event Study
Official title: Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Hyperopia
Corneal Infiltrative Events
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2009-07-10
Enrollment: 218
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Developing a Corneal Inflammatory Event (CIE)
timeFrame: up to 1 year
Secondary outcomes:
measure: Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
timeFrame: up to 1 year
measure: Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
timeFrame: up to 1 year
measure: Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
timeFrame: up to 1 year
measure: Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
timeFrame: up to 1 year
measure: Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Department of Ophthalmology University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Loretta Szczotka-Flynn, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.