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

Dry Eyes Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05169931
• Other study ID #: 21-001915
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 2022
• Est. completion date: May 2022

Study information

• Verified date: November 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective longitudinal study aims at evaluating the clinical efficacy of human amniotic fluid extract eye drops in the treatment of dry eye disease. 25 patients who are diagnosed with dry eye disease as defined by our criteria will be recruited from the cornea and dry eye clinic at Stein Eye Institute, UCLA. Pre-treatment baseline evaluations, 6 weeks, 12 weeks, and 24 weeks post treatment assessments will be performed by the principle investigator and co-investigator. All tests are considered non-invasive and are within the standard of practice in the evaluation for dry eye disease: (1) Ocular Surface Disease Index Questionnaire (OSDI); (2) Non-contact Tear Break-up Time (NITBUT); (3) Shirmer's test without anesthesia; (4) Ocular Surface Staining with Fluorescein and Lissamine green. Result of each test will be compared and analyzed to provide evidence of treatment efficacy. Treatment will be initiated for 12 weeks at a self-administered dose of one drop in both eyes two times per day. A follow-up of the study will be observed at the 24th week from the first day of treatment. All side effects and adverse events will be carefully observed and documented. Patients will be able to discontinue using the medication if they are not tolerating any side effects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eyes Chronic
• Keratoconjunctivitis Sicca

Intervention

Biological:
• RegenerEyes
Biologic eye drop

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

References & Publications (5)

Chen M, Chang CK, Lin SY, Chen M. A Pilot Study of the Short Term Effectiveness and Safety of Amniotic Fluid in Severe Dry Eye Disease. Med Hypothesis Discov Innov Ophthalmol. 2019 Summer;8(2):81-84. — View Citation

Murri MS, Moshirfar M, Birdsong OC, Ronquillo YC, Ding Y, Hoopes PC. Amniotic membrane extract and eye drops: a review of literature and clinical application. Clin Ophthalmol. 2018 Jun 18;12:1105-1112. doi: 10.2147/OPTH.S165553. eCollection 2018. Review. — View Citation

O'Neil EC, Henderson M, Massaro-Giordano M, Bunya VY. Advances in dry eye disease treatment. Curr Opin Ophthalmol. 2019 May;30(3):166-178. doi: 10.1097/ICU.0000000000000569. Review. — View Citation

Quinto GG, Camacho W, Castro-Combs J, Li L, Martins SA, Wittmann P, Campos M, Behrens A. Effects of topical human amniotic fluid and human serum in a mouse model of keratoconjunctivitis sicca. Cornea. 2012 Apr;31(4):424-30. doi: 10.1097/ICO.0b013e31823f0a64. — View Citation

Yeu E, Goldberg DF, Mah FS, Beckman KA, Luchs JI, Solomon JD, White DE, Gupta PK. Safety and efficacy of amniotic cytokine extract in the treatment of dry eye disease. Clin Ophthalmol. 2019 May 27;13:887-894. doi: 10.2147/OPTH.S203510. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index	Symptom Questionnaire	12 weeks
Secondary	Ocular Surface Staining Score		12 weeks
Secondary	Schirmer Score	Schirmer score after 5 minutes with anesthesia	12 weeks
Secondary	Non-contact Tear Break-up Time		12 weeks