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Dry Eyes ChronicEarly Phase 1NCT05169931

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

A Early Phase 1 study testing RegenerEyes in people with Dry Eyes Chronic, run by University of California, Los Angeles.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eyes Chronic
What is being tested?
RegenerEyes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2022to May 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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)
  • Corneal refractive surgery (e.g., laser in-situ keratomileusis [LASIK], photorefractive keratectomy [PRK], Intacs) within 6 months prior to enrollment
  • Cataract, eyelid surgery, or retinal surgery (in operating room) within 6 months prior to enrollment
  • Use of treatments that may interfere with the ocular surface and/or treatment efficacy:
  • Any in-office dry eye procedures (e.g., Intense Pulsed Light [IPL], LipiFlow®, nasolacrimal duct probing) within 30 days prior to enrollment
  • Use of anti-glaucoma drops, topical antihistamines drops, or topical steroid drops within 7 days prior to enrollment
  • Use of contact lenses. Patients willing to discontinue usage for 48 hours prior to each study visit will be eligible.
  • Use of scleral lens, such as the prosthetic replacement of the ocular surface ecosystem (PROSE) lens
  • 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.
  • Other important exclusion criteria:
  • Current smoker (within 1 year prior to enrollment).

About this study

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.

Being tested
RegenerEyes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegenerEyesBiological

    Biologic eye drop

Study groups in NCT05169931
Study groupRoleWhat they receive
Study groupExperimentalTreatment group to receive study drops (RegenerEyes) twice daily for 12 weeks
Receives: Biological: RegenerEyes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocular Surface Disease Index

    Symptom Questionnaire

    Measured: 12 weeks

Secondary outcomes (3)

  1. Ocular Surface Staining Score

    Measured: 12 weeks

  2. Schirmer Score

    Schirmer score after 5 minutes with anesthesia

    Measured: 12 weeks

  3. Non-contact Tear Break-up Time

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study startJan 2022 (estimated)
  3. Primary completionApr 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Why it stopped: Lack of funding/support

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169931
Sponsor's protocol ID
21-001915
Status last verified
Nov 2022
First submitted
14 Dec 2021
Last updated
10 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30883442

  • 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.

    PubMed 29950805

  • 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.

    PubMed 22290385

  • 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.

    PubMed 31213759

  • 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.

    PubMed 31263717

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing RegenerEyes in people with Dry Eyes Chronic, run by University of California, Los Angeles.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Surface Disease Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169931, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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