Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
54 participants
INTERVENTIONAL
2018-12-06
2020-02-01
Brief Summary
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There is evidence suggesting that substances in serum may help in the healing of epithelial defects, such as epidermal growth factor, fibroblast growth factor, fibronectin, and/or vitamin A. However, the precise serum factor responsible for alleviating the patient's complaints is currently not known.
SEDs are considered as a blood product under EU blood legislation (Directive 2002/98/EC), as well as in New Zealand and Australia. Commonly, autologous SEDs are used, but they are replaced more and more by allogeneic SEDs prepared from donor serum. Allogeneic SEDs are derived from healthy voluntary, non-remunerated male donors with blood group AB, and have the benefit of blood bank controlled quality. They can be delivered from stock and are therefore quickly available for each patient.
For application of eye drops, generally administration systems with a drop size of 40 to 50 µl are used, further on referred to as conventional sized eye drops. From previous studies done with medicinal eye drops, it has been shown that smaller eye drops, so called micro drops, can be just as effective and sometimes even superior to conventional drops for treatment of eye disease. If micro drops are just as effective or maybe even superior to conventional sized eye drops is currently unknown for the use of SEDs. This study will compare the feasibility and effectiveness of allogeneic serum micro eye drops using the mu-Drop applicator to the conventional sized allogeneic eye drops using the Meise applicator. Both systems have a closed manufacturing system.
Objective: The main objective is to determine whether the administration of allogeneic serum micro eye drops is non-inferior in terms of effectiveness and safety as compared to the conventional sized drops.
Main study parameters/endpoints: The primary endpoint is the improvement in OSDI score by using SEDs (OSDI score after treatment minus OSDI score before treatment), independent of the drop size, showing non-inferiority for the use of micro drops as compared to conventional sized drops.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Allogeneic conventional sized serum eye drops
Allogeneic conventional sized serum eye drops
allogeneic serum conventional sized drops (40-50 µL, administrated using the Meise applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
Allogeneic micro sized serum eye drops
Allogeneic serum micro eye drops (5-10 µL, administrated using the mu-Drop applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
Allogeneic micro sized serum eye drops
Allogeneic conventional sized serum eye drops
allogeneic serum conventional sized drops (40-50 µL, administrated using the Meise applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
Allogeneic micro sized serum eye drops
Allogeneic serum micro eye drops (5-10 µL, administrated using the mu-Drop applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
Interventions
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Allogeneic conventional sized serum eye drops
allogeneic serum conventional sized drops (40-50 µL, administrated using the Meise applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
Allogeneic micro sized serum eye drops
Allogeneic serum micro eye drops (5-10 µL, administrated using the mu-Drop applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
Eligibility Criteria
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Inclusion Criteria
* Age 16 years or older.
* Punctate staining of the cornea.
* Expected to benefit from SEDs.
* Not previously treated with SEDs.
Exclusion Criteria
* 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).
16 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Leiden University Medical Center
OTHER
UMC Utrecht
OTHER
Maastricht University Medical Center
OTHER
Amsterdam UMC, location AMC
OTHER
The Rotterdam Eye Hospital
UNKNOWN
Sanquin Research & Blood Bank Divisions
OTHER
Responsible Party
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Principal Investigators
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Cathrien Eggink, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Academic Medical Center Amsterdam
Amsterdam-Zuidoost, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Radboudumc
Nijmegen, , Netherlands
The Rotterdam Eye Hospital
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Vermeulen C, van der Burg LLJ, van Geloven N, Eggink CA, Cheng YYY, Nuijts RMMA, Wisse RPL, van Luijk CM, Nieuwendaal C, Remeijer L, van der Meer PF, de Korte D, Klei TRL. Allogeneic Serum Eye Drops: A Randomized Clinical Trial to Evaluate the Clinical Effectiveness of Two Drop Sizes. Ophthalmol Ther. 2023 Dec;12(6):3347-3359. doi: 10.1007/s40123-023-00827-5. Epub 2023 Oct 16.
Other Identifiers
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NL63119.091.17
Identifier Type: -
Identifier Source: org_study_id
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