N/A
N=314
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT00848198 ↗Enrolled (actual)
314
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L — 177; 14; 47; 61 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TearLab Corporation
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L |
177; 14; 47; 61 | — |
| PRIMARY Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm |
89; 13; 135; 62 | — |
| PRIMARY Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds |
161; 13; 63; 62 | — |
| PRIMARY Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 |
61; 1; 163; 74 | — |
| PRIMARY Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 |
115; 4; 109; 71 | — |
| PRIMARY Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 |
137; 16; 87; 59 | — |
| PRIMARY Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 |
131; 20; 93; 55 | — |
| SECONDARY Referent Values for Tear Osmolarity |
336.4; 315.0; 302.2 | — |
| SECONDARY Referent Values for Schirmer Test |
8.2; 13.9; 19.3 | — |
| SECONDARY Referent Values for Tear Film Breakup Time |
2.7; 6.1; 11.8 | — |
| SECONDARY Referent Values for Corneal Staining |
5.1; 1.7; 0.4 | — |
| SECONDARY Referent Values for Conjunctival Staining |
5.9; 2.6; 1.1 | — |
| SECONDARY Referent Values for Meibomian Gland Grading |
10.4; 5.6; 2.6 | — |
| SECONDARY Referent Values for Ocular Surface Disease Index |
41.2; 21.0; 5.5 | — |
Summary
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.
Eligibility Criteria
Inclusion Criteria
- Be between the ages of 18 and 79 years of age.
- Must understand and be able, willing and likely to fully comply with study procedures and restrictions.
Exclusion Criteria
- Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia..
- Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for Dry Eye Disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
- Active ocular allergy.
- LASIK or PRK surgery that was performed within one year of Visit 1.
- Started or changed the dose of chronic ocular medication within 30 days of visit 1.
- Contact lens worn within the past eight (8) hours.
- Any ophthalmologic drops within 2 hours of screening and visit 1 procedures.
- Pregnancy or lactation.
- Abnormality of nasolacrimal drainage (by history).
- Punctual plugs placement or cauterization within 30 days of Visit 1
- Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1.
- Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1.
- Known hypersensitivity to any of the agents used in testing i.e. sodium fluorescein, lissamine green, oxybuprocaine or proparacaine.
Data sourced from ClinicalTrials.gov (NCT00848198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.