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Amniotic Membrane Treatment for Hyposecretory Dry Eye

Sponsor
Hospital Nacional Profesor Alejandro Posadas (Other)
Overall Status
Completed
CT.gov ID
NCT05598242
Collaborator
(none)
37
Enrollment
3
Locations
2
Arms
10.4
Actual Duration (Months)
12.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Amniotic membrane extract eye drops (AMEED)
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
active-controlled, parallel-group trialactive-controlled, parallel-group trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Amniotic Membrane Treatment for Hyposecretory Dry Eye
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lisamina green conjunctival staining [1 month]

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

    Secondary Outcome Measures

    1. Fluorescein Corneal staining [1 month]

      fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment

    2. Schirmer's test [1 month]

      Schirmer´s test to asses lacrimal production whithout anesthesia

    3. TBUT [1 month]

      tear film break up time

    4. OSDI [1 month]

      severity of symptoms reported by patients according to the ocular surface disease index (OSDI)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Nacional Posadas El Palomar Buenos Aires Argentina 1649
    2 Hospital Nacional Prof. A. Posadas El Palomar Buenos Aires Argentina 1649
    3 Hospital Nacional Profesor A. Posadas El Palomar Buenos Aires Argentina 1684

    Sponsors and Collaborators

    • Hospital Nacional Profesor Alejandro Posadas

    Investigators

    • Principal Investigator: Emiliano F Ross, MD, assistant

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emiliano Facundo Ross, Medical doctor, Hospital Nacional Profesor Alejandro Posadas
    ClinicalTrials.gov Identifier:
    NCT05598242
    Other Study ID Numbers:
    • 192 LUPeSe/18 (ENM)
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emiliano Facundo Ross, Medical doctor, Hospital Nacional Profesor Alejandro Posadas
    dry eye
    autologous serum
    amniotic membrane extract eye drops
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Keratoconjunctivitis
    Syndrome
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Oct 28, 2022