Dry Eye SyndromeAmuSEDNCT03539159
Assessment of the Mu-Drop System for Serum Eye Drops
A study testing Allogeneic conventional sized serum eye drops and Allogeneic micro sized serum eye drops in people with Dry Eye Syndrome, run by Sanquin Research & Blood Bank Divisions at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Allogeneic conventional sized serum eye drops and Allogeneic micro sized serum eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesNetherlands
- Study dates
- 6 Dec 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Academic Medical Center Amsterdam
Amsterdam-Zuidoost
Carla, C.P. Nieuwendaal, c.p.nieuwendaal@amsterdamumc.nl
- Recruiting
Leiden University Medical Center
Leiden
Yanny J Cheng, MD, Y.Y.Cheng@lumc.nl
- Recruiting
Maastricht University Medical Center
Maastricht
R.M.M.A. A Nuijts, MD, rudy.nuijts@mumc.nl
- Recruiting
Radboudumc
Nijmegen
Cathrien Eggink, MD, cathrien.eggink@radboudumc.nl
- Recruiting
The Rotterdam Eye Hospital
Rotterdam
Lies, L. Remeijer, L.Remeijer@oogziekenhuis.nl
- Recruiting
UMC Utrecht
Utrecht
R.P.L Wisse, MD, R.P.L.Wisse@umcutrecht.nl
About this study
Official title: Allogenic Serum Micro Eye Drops Compared to Conventional Sized Eye Drops: A Prospective Randomized Non-inferiority, Investigator Masked, Cross-over Multicenter Clinical Study
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.
Read more
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.
- Conditions
- Dry Eye Syndrome
- Being tested
- Allogeneic conventional sized serum eye drops, Allogeneic micro sized serum eye drops
- Keywords
- Allogeneic serum eye drops, Micro eye drops, Cross-over multicenter trial, Ocular Surface Disease Index (OSDI)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic conventional sized serum eye dropsOther
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 dropsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic conventional sized serum eye drops | Experimental | Not described Receives: Other: Allogeneic conventional sized serum eye drops; Other: Allogeneic micro sized serum eye drops |
| Allogeneic micro sized serum eye drops | Experimental | Not described Receives: Other: Allogeneic conventional sized serum eye drops; Other: Allogeneic micro sized serum eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month after starting the intervention
Secondary outcomes (3)
Schirmer's test
Tear production in mm
Measured: One month after starting the intervention
Tear break up time
number of seconds the dry spot appears in the ter film
Measured: One month after starting the intervention
Corneal punctates
Percentage of affected surface after staining of the cornea
Measured: One month after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start6 Dec 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Leiden University Medical Center, UMC Utrecht, Maastricht University Medical Center, Amsterdam UMC, location AMC, The Rotterdam Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Cathrien Eggink, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539159
- Sponsor's protocol ID
- NL63119.091.17
- Acronym
- AmuSED
- Status last verified
- Sep 2019
- First submitted
- 16 May 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37843772
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Serum Micro Eye Drops Compared to Conventional Sized Eye Drops: A Prospective Randomized Non-inferiority, Investigator Masked, Cross-over Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT03539159
- Acronym / sponsor ID
- AmuSED / NL63119.091.17
- Conditions
- Dry Eye Syndrome
- Keywords
- Allogeneic serum eye drops, Micro eye drops, Cross-over multicenter trial, Ocular Surface Disease Index (OSDI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Leiden University Medical Center, UMC Utrecht, Maastricht University Medical Center, Amsterdam UMC, location AMC, The Rotterdam Eye Hospital
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic conventional sized serum eye drops | Experimental | Other: Allogeneic conventional sized serum eye drops, Other: Allogeneic micro sized serum eye drops |
| Allogeneic micro sized serum eye drops | Experimental | Other: Allogeneic conventional sized serum eye drops, Other: Allogeneic micro sized serum eye drops |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic conventional sized serum eye dropsallogeneic 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 | Other | Allogeneic conventional sized serum eye drops, Allogeneic micro sized serum eye drops |
| Allogeneic micro sized serum eye dropsAllogeneic 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 | Other | Allogeneic conventional sized serum eye drops, Allogeneic micro sized serum eye drops |
Primary outcome
Ocular Surface Disease Index (OSDI index)
Time frame: One month after starting the intervention
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.
3 secondary outcomes
Schirmer's test
Time frame: One month after starting the intervention
Tear break up time
Time frame: One month after starting the intervention
Corneal punctates
Time frame: One month after starting the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 37843772Vermeulen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathrien Eggink, MD principal investigator
Radboud University Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic conventional sized serum eye drops and Allogeneic micro sized serum eye drops in people with Dry Eye Syndrome, run by Sanquin Research & Blood Bank Divisions at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christie Vermeulen, PhD (06 10575008, c.vermeulen@sanquin.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI index) (time frame: One month after starting the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.