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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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.
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
Lisamina green conjunctival staining
changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage
Time frame: 1 month
Fluorescein Corneal staining
fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment
Time frame: 1 month
Schirmer's test
Schirmer´s test to asses lacrimal production whithout anesthesia
Time frame: 1 month
TBUT
tear film break up time
Time frame: 1 month
OSDI
severity of symptoms reported by patients according to the ocular surface disease index (OSDI)
Time frame: 1 month
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