NCT03085290

Brief Summary

Serum eye drops (SEDs) are used to treat patients with extreme dry eyes and other corneal defects. Serum is used in severe ophthalmic cases where conventional 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 all symptoms improve within 48 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. Commonly, autologous SEDs are used, but they are replaced more and more by allogeneic SEDs prepared from donor serum. Allogeneic SED are derived from healthy voluntary, non-remunerated male donors with blood group AB. The use of allogeneic SED could provide blood bank controlled quality, a safer product in larger quantities that is quickly available for each patient. No double-blind randomized trials are known to exist to detect a difference in result between the effect of allogeneic SED or autologous SED. This pilot study is intended to obtain insight in the ability of autologous and allogeneic SEDs to improve patient dry eye sensation. Our hypothesis is that autologous SEDs (in a 1:1 dilution with saline) result in an improvement of the patient dry eye sensation, while allogeneic SEDs (in a 1:1 dilution with saline) do not.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

March 2, 2017

Last Update Submit

April 3, 2019

Conditions

Dry Eye Syndrome

Keywords

dry eye syndromeserum eye drops

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index (OSDI)

    Normalized OSDI score

    One month after starting with serum eye drops

Secondary Outcomes (3)

  • Tear production (Schirmer's test)

    One month after starting with serum eye drops

  • Tear break up time

    One month after starting with serum eye drops

  • Corneal punctates

    One month after starting with serum eye drops

Study Arms (2)

Group A

EXPERIMENTAL

Subjects assigned to this arm will receive autologous serum eye drops first, followed by a washout period and then allogeneic serum eye drops.

Other: Autologous serum eye dropsOther: Allogeneic serum eye drops

Group B

EXPERIMENTAL

Subjects assigned to this arm will receive allogeneic serum eye drops first, followed by a washout period and then autologous serum eye drops.

Other: Autologous serum eye dropsOther: Allogeneic serum eye drops

Interventions

Autologous serum eye dropsOTHER

Autologous serum eye drop doses will be 6 times daily in each eye

Group AGroup B
Allogeneic serum eye dropsOTHER

Allogeneic serum eye drop doses will be 6 times daily in each eye

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic dry eye syndrome
  • age 18 or higher
  • expected to benefit from SEDs
  • can donate sufficient blood to prepare autologous SEDs
  • meet the donor guidelines of Sanquin (except for age, donation frequency and hemoglobin concentration)

You may not qualify if:

  • has corneal lesions more than punctates
  • has a history of unstable Herpes simplex virus (HSV) keratitis or is treated for HSV keratitis
  • currently already uses SEDs
  • pregnancy, lactating, or intending the become pregnant in the next 3 months
  • unable or unwilling to give informed consent
  • active (systemic) microbial infection
  • immuno-deficiency
  • poor venous access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Pieter F van der Meer, PhD

    Senior Scientist

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 21, 2017

Study Start

June 26, 2017

Primary Completion

October 8, 2018

Study Completion

October 8, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)