Dry Eye Disease Clinical Trial
Official title:
A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.
This is a global study of tear osmolarity using the OcuSense TearLab technology to compare tear samples of age and sex-matched normals with those with Dry Eye Disease (DED). Diagnosis of DED subjects will be established using objective and subjective tests. Positive responses to 3 out of 6 defined criteria determine subjects with DED. DED subjects will be further categorized by severity, using results from the objective and subjective tests. Subjects will be assessed at a single visit.
This is a multicenter study. A total of 500 subjects are expected to be enrolled at 10 sites
located in the United States, Europe and Japan. It is anticipated that each site will enroll
approximately 50 subjects.
Objectives:
- Primary: To establish OcuSense TearLab Osmometry (OTO) normative values, and referent
values to diagnose dry eye disease (DED)
- Secondary:
- To establish the relationship between OTO values and the severity of DED.
- To assess the effect on diagnostic accuracy of adding additional categories of
diagnostic test results, e.g. Ocular Surface Disease Index (OSDI) and /or Tear Break-up
Film Test (TBUT).
- To assess the effect of age and sex on the range of OTO values in normal subjects.
- To establish the variance of right eye (RE)/left eye (LE) OTO values in normal subjects
and in subjects with DED.
- To establish the accuracy of single eye OTO values versus bilateral values in
diagnosing DED.
- To assess the range of OTO values in symptomatic subjects without signs of DED and in
DED subjects of varying severity as judged by the clinical severity scale.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03216096 -
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
|
Phase 1 | |
| Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
| Completed |
NCT04656197 -
The Ocular Microbiome in Patients With Dry Eye Disease
|
||
| Completed |
NCT05031806 -
Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease
|
Phase 1 | |
| Completed |
NCT03688802 -
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
|
Phase 2 | |
| Completed |
NCT05213156 -
Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
|
Phase 4 | |
| Completed |
NCT04548427 -
Study to Evaluate the Efficacy and Safety of CKD-352
|
Phase 3 | |
| Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
| Completed |
NCT02254265 -
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
|
Phase 2/Phase 3 | |
| Completed |
NCT00395759 -
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
|
N/A | |
| Completed |
NCT00680108 -
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
|
Phase 2 | |
| Recruiting |
NCT06064071 -
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
|
N/A | |
| Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06375343 -
Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®
|
Phase 1 | |
| Completed |
NCT01468168 -
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
|
Phase 2 | |
| Completed |
NCT01014078 -
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
|
Phase 4 | |
| Completed |
NCT00799682 -
Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
|
Phase 4 | |
| Completed |
NCT05082974 -
Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)
|
Phase 3 | |
| Recruiting |
NCT06146881 -
Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
|
Phase 2 | |
| Completed |
NCT03292809 -
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
|
Phase 2/Phase 3 |