Assessment of the Mu-Drop System for Serum Eye Drops
AmuSED
Allogenic Serum Micro Eye Drops Compared to Conventional Sized Eye Drops: A Prospective Randomized Non-inferiority, Investigator Masked, Cross-over Multicenter Clinical Study
1 other identifier
interventional
54
1 country
6
Brief Summary
Rationale: Serum eye drops (SEDs) are used to treat patients with severe signs and symptoms of dry eyes and other corneal defects. Serum is used in severe ophthalmic cases where conventional treatment and/or eye drops (artificial tears) have insufficient effect. The use of SEDs in dry eye patients usually has a rapid effect. Most patients claim the effect to be instantaneous, and most symptoms improve within 48-72 hours. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedSeptember 19, 2019
September 1, 2019
12 months
May 16, 2018
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular Surface Disease Index (OSDI index)
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. The OSDI score falls between 0 and 100, ranging from normal, mild, moderate to severe dry eyes.
One month after starting the intervention
Secondary Outcomes (3)
Schirmer's test
One month after starting the intervention
Tear break up time
One month after starting the intervention
Corneal punctates
One month after starting the intervention
Study Arms (2)
Allogeneic conventional sized serum eye drops
EXPERIMENTALAllogeneic micro sized serum eye drops
EXPERIMENTALInterventions
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 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
You may qualify if:
- Subjects with severe signs and symptoms of dry eyes.
- Age 16 years or older.
- Punctate staining of the cornea.
- Expected to benefit from SEDs.
- Not previously treated with SEDs.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanquin Research & Blood Bank Divisionslead
- Radboud University Medical Centercollaborator
- Leiden University Medical Centercollaborator
- UMC Utrechtcollaborator
- Maastricht University Medical Centercollaborator
- Amsterdam UMC, location AMCcollaborator
- The Rotterdam Eye Hospitalcollaborator
Study Sites (6)
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
Related Publications (1)
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.
PMID: 37843772DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cathrien Eggink, MD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2018
First Posted
May 29, 2018
Study Start
December 6, 2018
Primary Completion
December 1, 2019
Study Completion
February 1, 2020
Last Updated
September 19, 2019
Record last verified: 2019-09