corneal lesions Dry eye syndrome
Conditions
Interventions
N.v.t.
Sponsors
Sanquin Bloedbank
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects with severe signs and symptoms of dry eyes Age 18 years or older Punctate staining of the cornea Expected to benefit from SEDs Not previously treated with SEDs
Exclusion criteria
Exclusion criteria: * Actively or previously treated for Herpes Simplex Virus (HSV) keratitis * Corneal lesions, more than punctate * Untreated Meibomian gland disease * Pregnant or lactating or intending to become pregnant in the next 3 months * Unable or unwilling to give informed consent * Active (systemic) microbial infection * The use of all types of contact lenses * Discontinuous use of medication that affects the dry eye sensation is not allowed (e.g. discontinuous use of local corticosteroids). Continuous use of co-medication, like lubricants, anti-glaucoma eye drops or other drops, that have to be used on a daily basis are allowed, and are expected to be used throughout the study period in both eyes (continuous use of the same medication is allowed if used at least one month prior to start of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement in OSDI score will be determined both for conventional sized and micro drops of allogeneic SEDs adjusted for randomization arm. An alpha of 0.05 will be considered to be statistically significant. In a second, non-inferiority, analysis the difference between conventional sized and micro drops will be determined, also adjusted for randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Using the same statistical model, the secondary study parameters will be analyzed. Other parameters will be included in the evaluation when part of the standard treatment and examination of the patient as part of their regular care. This might include, but is not limited to: visual acuity, refraction, eye pressure, corneal thickness, other eye medication. The ease of use of the systems will be included in the evaluation. For evaluation, the patients diary will be used, including experiences like how easy the system is to handle or specific problems for using as judged by the patients. | — |
Countries
Netherlands
Outcome results
None listed