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Amniotic Membrane Treatment for Hyposecretory Dry Eye

Primary Purpose

Dry Eye Syndromes, Sjogren Syndrome With Keratoconjunctivitis

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Amniotic membrane extract eye drops (AMEED)
Sponsored by
Hospital Nacional Profesor Alejandro Posadas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye, autologous serum, amniotic membrane extract eye drops

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 21 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

Exclusion Criteria:

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

Sites / Locations

  • Hospital Nacional Posadas
  • Hospital Nacional Prof. A. Posadas
  • Hospital Nacional Profesor A. Posadas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amniotic membrane extract

autologous serum eye drops

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fluorescein Corneal staining
fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment
Schirmer's test
Schirmer´s test to asses lacrimal production whithout anesthesia
TBUT
tear film break up time
OSDI
severity of symptoms reported by patients according to the ocular surface disease index (OSDI)

Full Information

First Posted
October 20, 2022
Last Updated
October 24, 2022
Sponsor
Hospital Nacional Profesor Alejandro Posadas
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1. Study Identification

Unique Protocol Identification Number
NCT05598242
Brief Title
Amniotic Membrane Treatment for Hyposecretory Dry Eye
Official Title
Amniotic Membrane Treatment for Hyposecretory Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nacional Profesor Alejandro Posadas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
This was a randomized, active-controlled, parallel-group trial. The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation. During de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ASED) or AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Sjogren Syndrome With Keratoconjunctivitis
Keywords
dry eye, autologous serum, amniotic membrane extract eye drops

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
active-controlled, parallel-group trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amniotic membrane extract
Arm Type
Experimental
Arm Description
patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days
Arm Title
autologous serum eye drops
Arm Type
Active Comparator
Arm Description
patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days
Intervention Type
Biological
Intervention Name(s)
Amniotic membrane extract eye drops (AMEED)
Other Intervention Name(s)
Autologous serum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lisamina green conjunctival staining
Description
changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Fluorescein Corneal staining
Description
fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment
Time Frame
1 month
Title
Schirmer's test
Description
Schirmer´s test to asses lacrimal production whithout anesthesia
Time Frame
1 month
Title
TBUT
Description
tear film break up time
Time Frame
1 month
Title
OSDI
Description
severity of symptoms reported by patients according to the ocular surface disease index (OSDI)
Time Frame
1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
frecuency of the illness
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21 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 Exclusion Criteria: glaucoma treatment surgical procedures within 3 months of the baseline evaluation precense of punctal plug patients that were human immunodeficiency virus positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano F Ross, MD
Organizational Affiliation
assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nacional Posadas
City
El Palomar
State/Province
Buenos Aires
ZIP/Postal Code
1649
Country
Argentina
Facility Name
Hospital Nacional Prof. A. Posadas
City
El Palomar
State/Province
Buenos Aires
ZIP/Postal Code
1649
Country
Argentina
Facility Name
Hospital Nacional Profesor A. Posadas
City
El Palomar
State/Province
Buenos Aires
ZIP/Postal Code
1684
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

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Amniotic Membrane Treatment for Hyposecretory Dry Eye

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