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Completed

NCT Number: NCT05598242

Amniotic Membrane Treatment for Hyposecretory Dry Eye

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Sjogren Syndrome With Keratoconjunctivitis

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Nacional Posadas, El Palomar, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Autologous serum

Primary outcomes

  1. Lisamina green conjunctival staining

    Time frame: 1 month

    changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage

Secondary outcomes

  1. Fluorescein Corneal staining

    Time frame: 1 month

    fluorescein corneal staining (FCS) score to demostrate corneal ephithelium involment

  2. Schirmer's test

    Time frame: 1 month

    Schirmer´s test to asses lacrimal production whithout anesthesia

  3. TBUT

    Time frame: 1 month

    tear film break up time

  4. OSDI

    Time frame: 1 month

    severity of symptoms reported by patients according to the ocular surface disease index (OSDI)

Sponsors and collaborators

Lead sponsor

Hospital Nacional Profesor Alejandro Posadas

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 28, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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