Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Dry Eyes Chronic
- Sponsor
- University of California, Los Angeles
- Primary Endpoint
- Ocular Surface Disease Index
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Saba K. Al-Hashimi, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Adults (18 years or older)
- •Presence of dry eye disease as defined as:
- •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
- •Systemic diseases or comorbidities that may cause severe or secondary dry eye:
- •Previous diagnosis of lymphoma, hepatitis C, HIV/AIDS, sarcoidosis, or amyloidosis that involves lacrimal glands
- •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)
- •Anatomical or neurological lid closure problems (e.g., Bell's palsy, cicatricial ectropion, Alzheimer's disease, Parkinson's disease) 4
- •Any history of chemotherapy, head or neck radiation treatment, or radioactive iodine treatment within 1 year prior to enrollment
- •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.
- •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.
- •Other ocular surface diseases or surgical history that may cause severe or secondary dry eye:
- •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)
- •Any history of surgery for glaucoma (e.g., trabeculectomy, tube shunt)
Outcomes
Primary Outcomes
Ocular Surface Disease Index
Time Frame: 12 weeks
Symptom Questionnaire
Secondary Outcomes
- Ocular Surface Staining Score(12 weeks)
- Schirmer Score(12 weeks)
- Non-contact Tear Break-up Time(12 weeks)