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

April 16, 2025 updated by: Glia, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts Eye and Ear Longwood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pro-ocular™
Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.
Drug: Pro-ocular™ topical gel
Topical gel for forehead dermal application
Placebo Comparator: Placebo
Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.
Drug: Placebo topical gel
Topical gel for forehead dermal application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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?
6 weeks
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?
10 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks
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.
2 weeks
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.
6 weeks
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.
10 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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?
1 year
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?
2 years
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?
1 year
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?
2 years
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.
1 year
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.
2 years
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.
1 year
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.
2 years
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.
1 year
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.
2 years
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.
1 year
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.
2 years
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.
1 year
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.
2 years
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.
1 year
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.
2 years
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.
1 year
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glia, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ORA, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhonghui K Luo, MD, PhD, Massachusetts Eye and Ear, Longwood

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • oGvHD-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data may be shared with other investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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