Dry Eye Disease (DED)
Conditions
Keywords
Dry Eye
Brief summary
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.
Detailed description
Dry Eye Disease (DED) is a chronic, progressive inflammatory multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. It is accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. DED creates a vicious cycle of ocular surface inflammation and damage. Beyond simple 'dryness', DED is recognized as a chronic, potentially progressive condition that can lead to significant visual impairment, corneal scarring, and a diminished quality of life (QoL) comparable to moderate-to-severe angina or dialysis. While standard therapies (lubricants, anti-inflammatory agents) manage symptoms, many patients suffer from refractory epithelial defects and keratitis. Human Amniotic Membrane (HAM) has been shown to possess anti-inflammatory, anti-scarring, and epithelial-promoting properties. The Human Amniotic Membrane (HAM) is the innermost layer of the placenta. It is uniquely suited for ocular surface reconstruction due to its complex biological scaffold.
Interventions
PROCEDUREStandard of Care (SOC)
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.
OTHERLyophilized Amnion Membrane Disc Allograft
Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.
Sponsors
Cellution Biologics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older. 2. Corneal Fluorescein Staining (CFS) Modified NEI grade \> 15 in the study eye. 3. Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye 4. Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months. 5. Participant must be able to follow study instructions, with the intention of completing all required visits 6. Participant must agree to attend the study visits required by the protocol. 7. Participant must be able and willing to complete follow-up. 8. Participant must be willing and able to participate in the informed consent process.
Exclusion criteria
1. Presence of persistent corneal epithelial defect or ulcer in either eye 2. Presence of active ocular infection in either eye 3. Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis 4. Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis 5. Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD) 6. Contact lens wear 7. History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK 8. Presence of cicatricial ocular surface diseases 9. History of procedures listed in 6.7.1 within the specified washout period CONFIDENTIAL Version No. 1 Version Date 06APR2026 Page PAGE 67 of NUMPAGES 67 VERSION 1.0 CELLUTION BIOLOGICS INC. 06 APRIL 2026 10. History or use of any medications listed in 6.7.2 within the specified washout period 11. Ophthalmic use of amniotic membrane in the past 90 days. 12. Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception. 13. Medical or psychological condition that, in the opinion of the investigator, may interfere with study. 14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics. 15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Epithelial Damage | 6-8 weeks | Evaluate the change of corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Symptoms | 6-8 weeks | Evaluate patient reported symptoms. |
| Stability of Tear Film | 6-8 weeks | Assess the stability of the tear film |
Contacts
STUDY_DIRECTORResearch Director
Cellution Biologics
Outcome results
None listed