Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment

This is an interventional treatment trial for Dry Eyes Chronic Read More

Inclusion Criteria:

• Adults (18 years or older)

• Presence of dry eye disease as defined as:

  1. Ocular Suface Disease Index (OSDI) score >13 AND EITHER i: Non-contact tear break-up time (NITBUT) < 10 seconds OR ii: Ocular Surface Staining (OSS) score > 1 in either eye

Exclusion Criteria:

1. Systemic diseases or comorbidities that may cause severe or secondary dry eye:

   1. Previous diagnosis of lymphoma, hepatitis C, HIV/AIDS, sarcoidosis, or amyloidosis that involves lacrimal glands
   2. Previous diagnosis of graft versus host disease (e.g., after bone marrow transplantation treatment for cancer) or cicatrizing conjunctivitis (e.g., Steven Johnson Syndrome, mucous membrane pemphigoid, trachoma)
   3. Anatomical or neurological lid closure problems (e.g., Bell's palsy, cicatricial ectropion, Alzheimer's disease, Parkinson's disease) 4
   4. Any history of chemotherapy, head or neck radiation treatment, or radioactive iodine treatment within 1 year prior to enrollment
   5. High dose oral or systemic steroids (equivalent to or greater than 5 mg prednisone) or immunosuppressive medication within 30 days prior to enrollment. Patients who are on stable dosing are eligible.
   6. Frequent or recent change in systemic medication regimen (e.g., diuretics, beta blockers, immunosuppressive medications, antidepressants that are known to interfere with dry eye) within 3 months prior to enrollment that may influence the ocular surface.

2. Other ocular surface diseases or surgical history that may cause severe or secondary dry eye:

   1. History of corneal dystrophy that in the opinion of the investigator is significantly affecting the ocular surface (e.g., significant anterior basement membrane dystrophy, Fuch's dystrophy with significant corneal edema and bullae, neurotrophic keratoconjunctivitis or corneal/conjunctival scarring including herpes simplex virus [HSV] or varicella zoster virus [VZV] keratitis)
   2. Any history of surgery for glaucoma (e.g., trabeculectomy, tube shunt)
   3. Corneal refractive surgery (e.g., laser in-situ keratomileusis [LASIK], photorefractive keratectomy [PRK], Intacs) within 6 months prior to enrollment
   4. Cataract, eyelid surgery, or retinal surgery (in operating room) within 6 months prior to enrollment

3. Use of treatments that may interfere with the ocular surface and/or treatment efficacy:

   1. Any in-office dry eye procedures (e.g., Intense Pulsed Light [IPL], LipiFlow®, nasolacrimal duct probing) within 30 days prior to enrollment
   2. Use of anti-glaucoma drops, topical antihistamines drops, or topical steroid drops within 7 days prior to enrollment
   3. Use of contact lenses. Patients willing to discontinue usage for 48 hours prior to each study visit will be eligible.
   4. Use of scleral lens, such as the prosthetic replacement of the ocular surface ecosystem (PROSE) lens
   5. Current use of topical lifitegrast (Xiidra®), topical cyclosporine (Restasis®), topical tacrolimus, or topical pimecrolimus. Patients willing to discontinue their due to insufficient benefit will be eligible.

4. Other important exclusion criteria:

   1. Current smoker (within 1 year prior to enrollment).