NCT05598242

Brief Summary

The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th. Researchers will compare against autologous serum eye drops effects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 20, 2022

Last Update Submit

October 24, 2022

Conditions

Dry Eye SyndromesSjogren Syndrome With Keratoconjunctivitis

Keywords

dry eyeautologous serumamniotic membrane extract eye drops

Outcome Measures

Primary Outcomes (1)

  • Lisamina green conjunctival staining

    changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage

    1 month

Secondary Outcomes (4)

  • Fluorescein Corneal staining

    1 month

  • Schirmer's test

    1 month

  • TBUT

    1 month

  • OSDI

    1 month

Study Arms (2)

Amniotic membrane extract

EXPERIMENTAL

patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days

Biological: Amniotic membrane extract eye drops (AMEED)

autologous serum eye drops

ACTIVE COMPARATOR

patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days

Biological: Amniotic membrane extract eye drops (AMEED)

Interventions

Amniotic membrane extract eye drops (AMEED)BIOLOGICAL

Following a 2-week wash out period, patients were allocated randomly to receive AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.

Also known as: Autologous serum
Amniotic membrane extractautologous serum eye drops

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfrecuency of the illness
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • dry eye related symptoms
  • Fluorescein Corneal Staining score of 4 or more
  • Lisamina Green Conjunctival score of 4 or more
  • a no-anesthesia Schirmer test value at 5' of 10 mm or less

You may not qualify if:

  • glaucoma treatment
  • surgical procedures within 3 months of the baseline evaluation
  • precense of punctal plug
  • patients that were human immunodeficiency virus positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Nacional Posadas

El Palomar, Buenos Aires, 1649, Argentina

Location

Hospital Nacional Prof. A. Posadas

El Palomar, Buenos Aires, 1649, Argentina

Location

Hospital Nacional Profesor A. Posadas

El Palomar, Buenos Aires, 1684, Argentina

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Emiliano F Ross, MD

    assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: active-controlled, parallel-group trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 28, 2022

Study Start

February 1, 2019

Primary Completion

September 1, 2019

Study Completion

December 15, 2019

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

AR(3)