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The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH) contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted patients with minimal or no astigmatism and no contraindications to CW lens use will be followed for 1 year. The primary outcome measure is the time to development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is corneal staining. Other key exploratory variables include bacterial contamination of study lenses and inflammatory mediators found in the tear film.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | healthy patients fit into lotrafilcon A contact lenses for continuous wear |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Corneal Inflammatory Events | Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea. | annual |
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Inclusion Criteria:
Exclusion Criteria:
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study volunteers from academic community willing to wear extended wear contact lenses
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| Name | Affiliation | Role |
|---|---|---|
| Loretta B Szczotka-Flynn, OD, MS | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20538985 | Result | Szczotka-Flynn L, Lass JH, Sethi A, Debanne S, Benetz BA, Albright M, Gillespie B, Kuo J, Jacobs MR, Rimm A. Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5421-30. doi: 10.1167/iovs.10-5456. Epub 2010 Jun 10. | |
| 19786927 | Result | Szczotka-Flynn LB, Bajaksouzian S, Jacobs MR, Rimm A. Risk factors for contact lens bacterial contamination during continuous wear. Optom Vis Sci. 2009 Nov;86(11):1216-26. doi: 10.1097/OPX.0b013e3181bbca18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational | healthy patients fit into lotrafilcon A contact lenses for continuous wear |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational | healthy patients fit into lotrafilcon A contact lenses for continuous wear |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Incidence of Corneal Inflammatory Events | Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea. | Posted | Mean | 95% Confidence Interval | annual incidence per 100 subjects | annual | eyes | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational | healthy patients fit into lotrafilcon A contact lenses for continuous wear |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| corneal inflammatory event | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Loretta Szczotka-Flynn OD, PhD | Case Western Reserve University Dept Ophthalmology & Visual Sciences | 216-844-3609 | loretta.szczotka@uhhospitals.org |
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tear samples contact lenses bacteria isolated from contact lenses
| 21173699 | Result | Szczotka-Flynn L, Benetz BA, Lass J, Albright M, Gillespie B, Kuo J, Fonn D, Sethi A, Rimm A. The association between mucin balls and corneal infiltrative events during extended contact lens wear. Cornea. 2011 May;30(5):535-42. doi: 10.1097/ICO.0b013e3181fb8644. |
| 24681609 | Derived | Tagliaferri A, Love TE, Szczotka-Flynn LB. Risk factors for contact lens-induced papillary conjunctivitis associated with silicone hydrogel contact lens wear. Eye Contact Lens. 2014 May;40(3):117-22. doi: 10.1097/ICL.0000000000000019. |
| years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| eyes |
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| 0 |
| 205 |
| 58 |
| 205 |
| Other non-Corneal Inflammatory Event | Eye disorders |
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