A Phase 3 interventional study of Amniotic membrane extract eye drops (AMEED) in Dry Eye Syndromes and Sjogren Syndrome With Keratoconjunctivitis, sponsored by Hospital Nacional Profesor Alejandro Posadas. Completed at 3 sites in Argentina. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Hospital Nacional Profesor Alejandro Posadas · Phase 3, Interventional, and Treatment
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 37 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Hospital Nacional Profesor Alejandro Posadas is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Also known as: Autologous serum
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Hospital Nacional Profesor Alejandro Posadas