Daily Wear Corneal Infiltrative Event Study (DWCIE)
This study has been completed.
Sponsor:
University Hospital Case Medical Center
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Loretta Szczotka-Flynn, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00937105
First received: July 9, 2009
Last updated: August 28, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia Hyperopia Corneal Infiltrative Events |
Device: lotrafilcon A contact lenses |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study) |
Resource links provided by NLM:
Further study details as provided by University Hospital Case Medical Center:
Primary Outcome Measures:
- Probability of developing a corneal infiltrative event during daily wear of silicone hydrogel contact lenses. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine if microbial contamination of lenses and lens cases is associated with the development of a corneal inflammatory event [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine if the risk for developing a corneal inflammatory event varies by presence or absence or corneal and/or conjunctival staining induced by lens or solution use. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine if the risk for developing a corneal inflammatory event varies by differing levels of bacterial contamination in combination with corneal and/or conjunctival staining induced by lens or solution use (i.e. interaction). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 218 |
| Study Start Date: | November 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: ReNu Multiplus and lotrafilcon A lenses |
Device: lotrafilcon A contact lenses
FDA approved soft contact lenses
Other Name: Air Optix Night & Day Aqua contact lenses
|
| Active Comparator: Clear Care solution and lotrafilcon A lenses |
Device: lotrafilcon A contact lenses
FDA approved soft contact lenses
Other Name: Air Optix Night & Day Aqua contact lenses
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 SimK 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 PMMA 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937105
Locations
| United States, Ohio | |
| Department of Ophthalmology University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
University Hospital Case Medical Center
Alcon Laboratories
Investigators
| Principal Investigator: | Loretta Szczotka-Flynn, OD, PhD | University Hospital Case Medical Center |
More Information
No publications provided
| Responsible Party: | Loretta Szczotka-Flynn, OD, PhD, University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT00937105 History of Changes |
| Other Study ID Numbers: | 001 |
| Study First Received: | July 9, 2009 |
| Last Updated: | August 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hyperopia Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013