NCT05598242

Amniotic Membrane Treatment for Hyposecretory Dry Eye

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Hospital Nacional Profesor Alejandro Posadas · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes
• Sjogren Syndrome With Keratoconjunctivitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-09-01
• Completion: 2019-12-15
• First posted: 2022-10-28
• Last updated: 2022-10-28

Locations

3 sites across 1 country: Argentina