Amniotic Membrane Treatment for Hyposecretory Dry Eye

Study Overview
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Brief Summary
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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
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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.

Official Title
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Amniotic Membrane Treatment for Hyposecretory Dry Eye

Conditions
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Dry Eye Syndromes, Sjogren Syndrome With Keratoconjunctivitis

Intervention / Treatment
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* Biological: Amniotic membrane extract eye drops (AMEED)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: active-controlled, parallel-group trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amniotic membrane extract<br>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)<br>* 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.<br>* Other names: Autologous serum;|
| Active Comparator: autologous serum eye drops<br>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)<br>* 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.<br>* Other names: Autologous serum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lisamina green conjunctival staining | changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, autologous serum, amniotic membrane extract eye drops