Amniotic Membrane Treatment for Hyposecretory Dry Eye

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Sjogren Syndrome With Keratoconjunctivitis
• Intervention / Treatment: Biological: Amniotic membrane extract eye drops (AMEED)

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • El Palomar, Buenos Aires, Argentina, 1684
      • Hospital Nacional Profesor A. Posadas
    • El Palomar, Buenos Aires, Argentina, 1649
      • Hospital Nacional Posadas
    • El Palomar, Buenos Aires, Argentina, 1649
      • HOSPITAL NACIONAL PROF. A. POSADAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic membrane extract; 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); 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.; Other Names: Autologous serum
Active Comparator: autologous serum eye drops; 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); 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.; Other Names: Autologous serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lisamina green conjunctival staining	changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein Corneal staining	fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment	1 month
Schirmer's test	Schirmer´s test to asses lacrimal production whithout anesthesia	1 month
TBUT	tear film break up time	1 month
OSDI	severity of symptoms reported by patients according to the ocular surface disease index (OSDI)	1 month

Collaborators and Investigators

• Sponsor: Hospital Nacional Profesor Alejandro Posadas
• Investigators: Principal Investigator: Emiliano F Ross, MD, Assistant

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: dry eye; autologous serum; amniotic membrane extract eye drops
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome; Keratoconjunctivitis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: 192 LUPeSe/18 (ENM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No