Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2019-02-01
2019-12-15
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amniotic membrane extract
patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days
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.
autologous serum eye drops
patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* surgical procedures within 3 months of the baseline evaluation
* precense of punctal plug
* patients that were human immunodeficiency virus positive
21 Years
FEMALE
No
Sponsors
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Hospital Nacional Profesor Alejandro Posadas
OTHER
Responsible Party
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Emiliano Facundo Ross
Medical doctor
Principal Investigators
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Emiliano F Ross, MD
Role: PRINCIPAL_INVESTIGATOR
assistant
Locations
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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
Countries
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Other Identifiers
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192 LUPeSe/18 (ENM)
Identifier Type: -
Identifier Source: org_study_id
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