An observational study in Dry Eye Disease, sponsored by Novaliq GmbH. Completed at 2 sites in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-10-06.
Sponsored by Novaliq GmbH · Observational
This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's enrollment of 30 is below the median of 89 across 176 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Novaliq GmbH is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with mild to moderate hyper-evaporative dry eye disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: NovaTears® Eye Drops
Topical eye drops for lubrication of the ocular surface
Efficacy measured by routine ophthalmological assessment
Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia.
Time frame: 5 to 7 weeks
Local Tolerability measured by ophthalmological assessment
Time frame: 5 to 7 weeks
The record gives a start of Dec 2013, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Novaliq GmbH