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A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease

ConditionDry Eye Disease (DED)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellution Biologics

About this trial

To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older.

Corneal Fluorescein Staining (CFS) Modified NEI grade > 15 in the study eye.

Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye

Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.

Disqualifiers

Presence of persistent corneal epithelial defect or ulcer in either eye

Presence of active ocular infection in either eye

Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis

Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis

Trial design

Design model

Single group

Treatments tested in this trial

  • Standard of Care (SOC)

    Procedure/Surgery

    Standard of care is to perform eye cleansing with sterile saline, application of one drop of Ofloxacin prophylactically to eye, application of topical anesthetic, application of bandage lens to eye, application of drops of saline as needed to ensure hydration, taping eye partially shut and continuation of preservative free topical lubricating drops.

  • Lyophilized Amnion Membrane Disc Allograft

    Other intervention

    Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: FD-AM + SoCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Reduction of Corneal Epithelial Damage

To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.

Time frame
6-8 weeks

Secondary outcomes

1

Improvement in Patient Reported Symptoms

To evaluate improvement in patient reported symptoms (OSDI).

Time frame
6-8 weeks
2

Stability of Tear Film

To assess the stability of the tear film (TBUT).

Time frame
6-8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cellution Biologics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: