NL-OMON44587CompletedNot Applicable
Allogeneic serum micro eye drops compared to conventional sized eye drops: a prospective randomized non-inferiority, investigator-masked, cross-over multicenter clinical study. - Assessment of the mu-Sized Serum Eye Drops (AmuSED)
Sanquin Bloedbank0 sites54 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •* 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).
Investigators
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