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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amniotic membrane extract | Experimental | patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days |
|
| autologous serum eye drops | Active Comparator | patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic membrane extract eye drops (AMEED) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lisamina green conjunctival staining | changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
frecuency of the illness
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| Name | Affiliation | Role |
|---|---|---|
| Emiliano F Ross, MD | assistant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Posadas | El Palomar | Buenos Aires | 1649 | Argentina | ||
| Hospital Nacional Prof. A. Posadas |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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active-controlled, parallel-group trial
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|
| 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 |
| El Palomar |
| Buenos Aires |
| 1649 |
| Argentina |
| Hospital Nacional Profesor A. Posadas | El Palomar | Buenos Aires | 1684 | Argentina |