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

Glia, LLC33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Ocular Graft-versus-host Disease

Interventions

Pro-ocular™ topical gelDRUG

Topical gel for forehead dermal application

Placebo topical gelDRUG

Topical gel for forehead dermal application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female of any race, at least 18 years of age at Visit 1 Screening. 2. Has the diagnosis of chronic ocular GvHD. 3. Has an NIH Consensus Eye Score of at least 2. 4. 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. 5. One or more signs from the list of chronic ocular GvHD signs below 6. Has provided verbal and written informed consent. 7. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits. Exclusion Criteria: 1. Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study. 2. Anticipate major changes in systemic GvHD management during study period. 3. 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. 4. Anticipate change of vision correction or anticipate any ocular procedures during study period. 5. A woman who is pregnant, nursing an infant, or planning a pregnancy. 6. 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. 7. Has a known adverse reaction and/or sensitivity to the study drug or its components. 8. Unwilling to cease the use of sunscreen on the forehead or eye area. 9. Intraocular pressure \>22 mm Hg at screening visit with or without ongoing glaucoma treatment. 10. Currently enrolled in an investigational drug or device study for chronic ocular GvHD.

Locations (1)

Massachusetts Eye and Ear Longwood

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Modified SANDE Questionnaire - Frequency, Change From Baseline

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?

Time frame: 2 weeks

Corneal Fluorescein Stain - Central, Change From Baseline

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.

Time frame: 2 weeks

Secondary Outcomes

Modified SANDE Questionnaire - Frequency, Change From Baseline

Time frame: 6 weeks

Modified SANDE Questionnaire - Frequency, Change From Baseline

Time frame: 10 weeks

Corneal Fluorescein Stain - Central, Change From Baseline

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.

Time frame: 6 weeks

Corneal Fluorescein Stain - Central, Change From Baseline

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 10 weeks

Modified SANDE Questionnaire - Global, Change From Baseline

Time frame: 2 weeks

Modified SANDE Questionnaire - Global, Change From Baseline

Time frame: 6 weeks

Modified SANDE Questionnaire - Global, Change From Baseline

Time frame: 10 weeks

Corneal Fluorescein Stain - Total, Change From Baseline

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.

Time frame: 2 weeks

Corneal Fluorescein Stain - Total, Change From Baseline

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.

Time frame: 6 weeks

Corneal Fluorescein Stain - Total, Change From Baseline

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.

Time frame: 10 weeks

Blurred Vision, Change From Baseline

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.

Time frame: 2 weeks

Blurred Vision, Change From Baseline

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.

Time frame: 6 weeks

Blurred Vision, Change From Baseline

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.

Time frame: 10 weeks

Photophobia, Change From Baseline

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.

Time frame: 2 weeks

Photophobia, Change From Baseline

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.

Time frame: 6 weeks

Photophobia, Change From Baseline

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.

Time frame: 10 weeks

Lid Edema, Change From Baseline

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.

Time frame: 2 weeks

Lid Edema, Change From Baseline

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.

Time frame: 6 weeks

Lid Edema, Change From Baseline

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.

Time frame: 10 weeks

Lid Erythema, Change From Baseline

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.

Time frame: 2 weeks

Lid Erythema, Change From Baseline

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.

Time frame: 6 weeks

Lid Erythema, Change From Baseline

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.

Time frame: 10 weeks

Lid Margin Ulceration, Change From Baseline

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.

Time frame: 2 weeks

Lid Margin Ulceration, Change From Baseline

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.

Time frame: 6 weeks

Lid Margin Ulceration, Change From Baseline

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.

Time frame: 10 weeks

Conjunctival Hyperemia, Change From Baseline

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.

Time frame: 2 weeks

Conjunctival Hyperemia, Change From Baseline

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.

Time frame: 6 weeks

Conjunctival Hyperemia, Change From Baseline

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.

Time frame: 10 weeks

Dryness, Change From Baseline

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.

Time frame: 2 weeks

Dryness, Change From Baseline

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.

Time frame: 6 weeks

Dryness, Change From Baseline

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.

Time frame: 10 weeks

Ocular Pain, Change From Baseline

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.

Time frame: 2 weeks

Ocular Pain, Change From Baseline

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.

Time frame: 6 weeks

Ocular Pain, Change From Baseline

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.

Time frame: 10 weeks

Airflow Sensitivity, Change From Baseline

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.

Time frame: 2 weeks

Airflow Sensitivity, Change From Baseline

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.

Time frame: 6 weeks

Airflow Sensitivity, Change From Baseline

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.

Time frame: 10 weeks