Assessment of the Mu-Drop System for Serum Eye Drops (AmuSED)

September 17, 2019 updated by: Sanquin Research & Blood Bank Divisions

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allogeneic conventional sized serum eye drops
Other: 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
Other: 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
Experimental: Allogeneic micro sized serum eye drops
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month after starting the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer's test
Time Frame: One month after starting the intervention
Tear production in mm
One month after starting the intervention
Tear break up time
Time Frame: One month after starting the intervention
number of seconds the dry spot appears in the ter film
One month after starting the intervention
Corneal punctates
Time Frame: One month after starting the intervention
Percentage of affected surface after staining of the cornea
One month after starting the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanquin Research & Blood Bank Divisions

Collaborators

Radboud University Medical Center
Maastricht University Medical Center
UMC Utrecht
Leiden University Medical Center
Amsterdam UMC, location AMC
The Rotterdam Eye Hospital

Investigators

  • Principal Investigator: Cathrien Eggink, MD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL63119.091.17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndrome

Clinical Trials on Allogeneic conventional sized serum eye drops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe