Dry Eye Syndromes, Sjogren Syndrome With Keratoconjunctivitis
Conditions
Keywords
dry eye, autologous serum, amniotic membrane extract eye drops
Brief summary
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
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.
Interventions
BIOLOGICALAmniotic 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.
Sponsors
Hospital Nacional Profesor Alejandro Posadas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
active-controlled, parallel-group trial
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lisamina green conjunctival staining | 1 month | changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein Corneal staining | 1 month | fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment |
| Schirmer's test | 1 month | Schirmer´s test to asses lacrimal production whithout anesthesia |
| TBUT | 1 month | tear film break up time |
| OSDI | 1 month | severity of symptoms reported by patients according to the ocular surface disease index (OSDI) |
Countries
Argentina
Outcome results
None listed