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NCT05598242 Clinical Trial

Amniotic Membrane Treatment for Hyposecretory Dry Eye

Dry Eye Syndromes Clinical Trial

Official title:
Amniotic Membrane Treatment for Hyposecretory Dry Eye

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05598242
Other study ID # 192 LUPeSe/18 (ENM)
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 1, 2019
Est. completion date December 15, 2019

Study information
Verified date October 2022
Source Hospital Nacional Profesor Alejandro Posadas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date December 15, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Argentina Hospital Nacional Posadas El Palomar Buenos Aires
Argentina Hospital Nacional Prof. A. Posadas El Palomar Buenos Aires
Argentina Hospital Nacional Profesor A. Posadas El Palomar Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Hospital Nacional Profesor Alejandro Posadas

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lisamina green conjunctival staining changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage 1 month
Secondary Fluorescein Corneal staining fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment 1 month
Secondary Schirmer's test Schirmer´s test to asses lacrimal production whithout anesthesia 1 month
Secondary TBUT tear film break up time 1 month
Secondary OSDI severity of symptoms reported by patients according to the ocular surface disease index (OSDI) 1 month
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