Amniotic Membrane Treatment for Hyposecretory Dry Eye

Phase 3

Completed

• Conditions: Dry Eye Syndromes; Sjogren Syndrome With Keratoconjunctivitis
• Interventions: Biological: Amniotic membrane extract eye drops (AMEED)

• Registration Number: NCT05598242
• Lead Sponsor: Hospital Nacional Profesor Alejandro Posadas

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-15
• Status Verified: 2022-10
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous serum eye drops	Amniotic membrane extract eye drops (AMEED)	patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days
Amniotic membrane extract	Amniotic membrane extract eye drops (AMEED)	patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days

Primary Outcome Measures

Name	Time	Method
Lisamina green conjunctival staining	1 month	changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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, Argentina