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Completed

NCT Number: NCT03298815

Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.

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Key information

Conditions

Ocular Graft Versus Host Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

About this study

This is a randomized (to each eye, within patient), double-blinded, placebo-controlled study of the efficacy of Processed Amniotic Fluid (pAF) in patients with hematologic malignancies who have undergone Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and are diagnosed with Chronic Graft Verses Host Disease of the eye.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed within 5 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following symptoms:
  • Dry eye symptoms partially affecting (requiring lubricant drops > 3 x per day or punctal plugs, or thermally cauterized puncta) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL)
  • Unable to work because of ocular symptoms
  • Loss of vision due to keratoconjunctivitis sicca (KCS)
  • Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
  • Patients who are 18 years of age or older.
  • Willing and able to provide informed consent.

Exclusion criteria

  • Patients who have any other reversible cause for dry eye at the time of accrual.
  • More than 3 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
  • Relapsed malignancy at time of accrual after the most recent transplantation
  • A difference in dryness between both eyes of more than 2 points of the grading provided by the International Dry Eye Workshop (DEWS) 2007 report
  • Patients who are pregnant or plan to become pregnant while participating in the study.
  • Patients who are not willing to discontinue the use of any eye drops, with the exception of non-medicated lubricant eye drops (artificial tears). All eye drops (excluding non-medicated lubricant eye drops) must be stopped at least seven days before treatment with pAF.
  • Inability to comply with the investigational plan and visit schedule for any reason, in the judgement of the investigator.

Treatment and study plan

Amniotic Fluid Eye Drops (AFED)

Biological

One drop (0.25 mL) in one eye twice daily for up to 3 months

Saline solution

Other

One drop (0.25 mL) in the other eye twice daily for up to 3 months

Primary outcomes

  1. Overall Response Rate

    Time frame: 30 days

    Response is a composite of the NIH Consensus Conference (CC) for assessment of response in chronic GVHD (eye score) and the International Dry Eye Workshop (DEWS) grading scale. Responders would be defined as a one point improvement in the dry eye grading scale (DEWS), without worsening in the eye score.

Secondary outcomes

  1. Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 30 Days

    Time frame: baseline and 30 days

    Change in Quality of Life questionnaire from baseline to 30 days. FACT-G is a combination score of physical, social/family, emotional, and functional well-being. The score ranges from 0 to 108. The higher the score, the better the quality of life.

  2. Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 60 Days

    Time frame: baseline and 60 days

    Change in Quality of Life questionnaire from baseline to 60 days. FACT-G is a combination score of physical, social/family, emotional, and functional well-being. The score ranges from 0 to 108. The higher the score, the better the quality of life.

  3. Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 100 Days

    Time frame: baseline and 100 days

    Change in Quality of Life questionnaire from baseline to 100 days. FACT-G is a combination score of physical, social/family, emotional, and functional well-being. The score ranges from 0 to 108. The higher the score, the better the quality of life.

  4. Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 30 Days

    Time frame: baseline and 30 days

    Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms) from baseline to 30 days.

  5. Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 60 Days

    Time frame: baseline and 60 days

    Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).

  6. Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 100 Days

    Time frame: baseline and 100 days

    Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).

  7. Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline to 30 Days

    Time frame: baseline and 30 days

    Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.

  8. Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 60 Days

    Time frame: baseline and 60 days

    Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.

  9. Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 100 Days

    Time frame: baseline and 100 days

    Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.

  10. Change in Pain Assessment From Baseline to 60 Days

    Time frame: baseline and 60 days

    Change in patient reported pain level per treatment eye using 0-10 pain rating scale with zero being no pain to 10 being very severe pain. Each individual pain score was used to estimate a regression slope for each eye with pain as the outcome and day of pAF treatments as the explanatory variable.

  11. Changes in Visual Acuity

    Time frame: baseline, 30 days, 60 days, and 100 days

    Ophthalmologic assessment to determine changes in visual acuity related to the administration of pAF.

  12. Effects on the Corneal Surface

    Time frame: Up to 100 days

    Ophthalmologic assessment to determine the effects of treatment with pAF on the corneal surface of patients with ocular chronic GVHD.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 2, 2017
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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