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Completed

NCT Number: NCT03990051

Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.

To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.

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Key information

Conditions

Chronic Ocular Graft-versus-host Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts Eye and Ear Longwood

Boston, Massachusetts, 02115, United States

About this study

Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients.

A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill.

Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female of any race, at least 18 years of age at Visit 1 Screening.
  • Has the diagnosis of chronic ocular GvHD.
  • Has an NIH Consensus Eye Score of at least 2.
  • On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.
  • One or more signs from the list of chronic ocular GvHD signs below
  • Has provided verbal and written informed consent.
  • Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.

Exclusion criteria

  • Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.
  • Anticipate major changes in systemic GvHD management during study period.
  • Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.
  • Anticipate change of vision correction or anticipate any ocular procedures during study period.
  • A woman who is pregnant, nursing an infant, or planning a pregnancy.
  • A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period.
  • Has a known adverse reaction and/or sensitivity to the study drug or its components.
  • Unwilling to cease the use of sunscreen on the forehead or eye area.
  • Intraocular pressure >22 mm Hg at screening visit with or without ongoing glaucoma treatment.
  • Currently enrolled in an investigational drug or device study for chronic ocular GvHD.

Treatment and study plan

Pro-ocular™ topical gel

Drug

Topical gel for forehead dermal application

Placebo Topical Gel

Drug

Topical gel for forehead dermal application

Primary outcomes

  1. Modified SANDE Questionnaire - Frequency, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.

    Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

  2. Corneal Fluorescein Stain - Central, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

Secondary outcomes

  1. Modified SANDE Questionnaire - Frequency, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.

    Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

  2. Modified SANDE Questionnaire - Frequency, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.

    Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

  3. Corneal Fluorescein Stain - Central, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

  4. Corneal Fluorescein Stain - Central, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

  5. Modified SANDE Questionnaire - Global, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.

    Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

  6. Modified SANDE Questionnaire - Global, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.

    Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

  7. Modified SANDE Questionnaire - Global, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.

    Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

  8. Corneal Fluorescein Stain - Total, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

  9. Corneal Fluorescein Stain - Total, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

  10. Corneal Fluorescein Stain - Total, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

  11. Blurred Vision, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.

    Blurred vision symptom is reported by participant.

  12. Blurred Vision, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.

    Blurred vision symptom is reported by participant.

  13. Blurred Vision, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.

    Blurred vision symptom is reported by participant.

  14. Photophobia, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.

    Sensitivity to light symptom is reported by participant.

  15. Photophobia, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.

    Sensitivity to light symptom is reported by participant.

  16. Photophobia, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.

    Sensitivity to light symptom is reported by participant.

  17. Lid Edema, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid edema is viewed by slit lamp without stain.

  18. Lid Edema, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid edema is viewed by slit lamp without stain.

  19. Lid Edema, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid edema is viewed by slit lamp without stain.

  20. Lid Erythema, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid erythema is viewed by slit lamp without stain.

  21. Lid Erythema, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid erythema is viewed by slit lamp without stain.

  22. Lid Erythema, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid erythema is viewed by slit lamp without stain.

  23. Lid Margin Ulceration, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid margin ulceration is viewed by slit lamp without stain.

  24. Lid Margin Ulceration, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid margin ulceration is viewed by slit lamp without stain.

  25. Lid Margin Ulceration, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid margin ulceration is viewed by slit lamp without stain.

  26. Conjunctival Hyperemia, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Conjunctival hyperemia is viewed by slit lamp without stain.

  27. Conjunctival Hyperemia, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Conjunctival hyperemia is viewed by slit lamp without stain.

  28. Conjunctival Hyperemia, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Conjunctival hyperemia is viewed by slit lamp without stain.

  29. Dryness, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Dryness symptom is reported by participant.

  30. Dryness, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Dryness symptom is reported by participant.

  31. Dryness, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Dryness symptom is reported by participant.

  32. Ocular Pain, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Ocular pain symptom is reported by participant.

  33. Ocular Pain, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Ocular pain symptom is reported by participant.

  34. Ocular Pain, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Ocular pain symptom is reported by participant.

  35. Airflow Sensitivity, Change From Baseline

    Time frame: 2 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Airflow sensitivity symptom is reported by participant.

  36. Airflow Sensitivity, Change From Baseline

    Time frame: 6 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Airflow sensitivity symptom is reported by participant.

  37. Airflow Sensitivity, Change From Baseline

    Time frame: 10 weeks

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.

    Airflow sensitivity symptom is reported by participant.

Other outcomes

  1. Modified SANDE Questionnaire - Frequency

    Time frame: 1 year

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

  2. Modified SANDE Questionnaire - Frequency

    Time frame: 2 years

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

  3. Modified SANDE Questionnaire - Global

    Time frame: 1 year

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?

  4. Modified SANDE Questionnaire - Global

    Time frame: 2 years

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?

  5. Corneal Fluorescein Stain - Central

    Time frame: 1 year

    Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

  6. Corneal Fluorescein Stain - Central

    Time frame: 2 years

    Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

  7. Corneal Fluorescein Stain - Total

    Time frame: 1 year

    Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

  8. Corneal Fluorescein Stain - Total

    Time frame: 2 years

    Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

  9. Blurred Vision

    Time frame: 1 year

    Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.

    Blurred vision symptom is reported by participant.

  10. Blurred Vision

    Time frame: 2 years

    Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.

    Blurred vision symptom is reported by participant.

  11. Lid Edema

    Time frame: 1 year

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  12. Lid Edema

    Time frame: 2 years

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  13. Lid Erythema

    Time frame: 1 year

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  14. Lid Erythema

    Time frame: 2 years

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  15. Lid Ulceration

    Time frame: 1 year

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  16. Lid Ulceration

    Time frame: 2 years

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  17. Conjunctival Hyperemia

    Time frame: 1 year

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.

  18. Conjunctival Hyperemia

    Time frame: 2 years

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.

    Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Sponsors and collaborators

Lead sponsor

Glia, LLC

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study title

Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2019
Registry last updated
May 6, 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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