Amniotic Membrane Treatment for Hyposecretory Dry Eye

Hospital Nacional Profesor Alejandro Posadas

Status and phase: Completed; Phase 3

Conditions: Sjogren Syndrome With Keratoconjunctivitis; Dry Eye Syndromes

Treatments: Biological: Amniotic membrane extract eye drops (AMEED)

Study type: Interventional

Funder types: Other

Identifiers

NCT05598242

192 LUPeSe/18 (ENM)

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Amniotic membrane extract

Experimental group

Description:

patients receive amniotic membrane eye drops (AMEED) as 1 drop in each eye 6 times daily, 30 days

Treatment:

Biological: Amniotic membrane extract eye drops (AMEED)

autologous serum eye drops

Active Comparator group

Description:

patients receive autologous serum eye drops (ASED) as 1 drop in each eye 6 times daily, 30 days

Treatment:

Biological: Amniotic membrane extract eye drops (AMEED)