Chronic Ocular Graft-versus-host DiseasePhase 2NCT03990051

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

A Phase 2 study testing Pro-ocular™ topical gel in people with Chronic Ocular Graft-versus-host Disease, run by Glia, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Ocular Graft-versus-host Disease
What is being tested?: Pro-ocular™ topical gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2019to 19 Nov 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Longwood
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Chronic Ocular Graft-versus-host Disease
Being tested: Pro-ocular™ topical gel, Placebo topical gel

What participants receive

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

Pro-ocular™ topical gelDrug
Topical gel for forehead dermal application
Placebo topical gelDrug
Topical gel for forehead dermal application

Study groups in NCT03990051
Study group	Role	What they receive
Pro-ocular™	Experimental	Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime. Receives: Drug: Pro-ocular™ topical gel
Placebo	Placebo comparator	Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime. Receives: Drug: Placebo topical gel

What is being measured

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

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?
Measured: 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.
Measured: 2 weeks

Secondary outcomes (37)

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?
Measured: 6 weeks
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?
Measured: 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.
Measured: 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.
Measured: 10 weeks
Modified SANDE Questionnaire - Global, 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? Global score is sqrt of Frequency x Severity.
Measured: 2 weeks
Modified SANDE Questionnaire - Global, 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? Global score is sqrt of Frequency x Severity.
Measured: 6 weeks
Modified SANDE Questionnaire - Global, 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? Global score is sqrt of Frequency x Severity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks

Timeline

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

17 Oct 201919 Nov 2021

First posted18 Jun 2019
Study start17 Oct 2019
Primary completion31 Oct 2021
Study completion19 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The double-masked phase involves placebo controlled administration of study drug for 70 days or 10 weeks. Subsequently the placebo group will receive the active study drug of 42 days or 6 weeks. Long term open label phase to 27 months.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03990051
Sponsor's protocol ID: oGvHD-1
Status last verified: Nov 2024
First submitted: 11 Jun 2019
Last updated: 6 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Data may be shared with other investigators.

Publications

Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14.
PubMed 33942724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Ocular Graft-versus-host Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation.
ClinicalTrials.gov ID: NCT03990051
Acronym / sponsor ID: oGvHD-1
Conditions: Chronic Ocular Graft-versus-host Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Glia, LLCIndustry (pharma, biotech, devices)
Collaborators: ORA, Inc.
Study start: 17 Oct 2019 (actual)
Primary completion: 31 Oct 2021 (actual)
Study completion: 19 Nov 2021 (actual)
First posted: 18 Jun 2019 (actual)
Results: Posted 6 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: The double-masked phase involves placebo controlled administration of study drug for 70 days or 10 weeks. Subsequently the placebo group will receive the active study drug of 42 days or 6 weeks. Long term open label phase to 27 months.

Arm	Type	Receives
Pro-ocular™	Experimental	Drug: Pro-ocular™ topical gelPro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.
Placebo	Placebo comparator	Drug: Placebo topical gelVehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pro-ocular™ topical gelTopical gel for forehead dermal application	Drug	Pro-ocular™
Placebo topical gelTopical gel for forehead dermal application	Drug	Placebo

Primary outcome

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?
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.

37 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
Time frame: 6 weeks
Corneal Fluorescein Stain - Central, Change From Baseline
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
Time frame: 2 weeks
Corneal Fluorescein Stain - Total, Change From Baseline
Time frame: 6 weeks
Corneal Fluorescein Stain - Total, Change From Baseline
Time frame: 10 weeks
Blurred Vision, Change From Baseline
Time frame: 2 weeks
Blurred Vision, Change From Baseline
Time frame: 6 weeks
Blurred Vision, Change From Baseline
Time frame: 10 weeks
Photophobia, Change From Baseline
Time frame: 2 weeks
Photophobia, Change From Baseline
Time frame: 6 weeks
Photophobia, Change From Baseline
Time frame: 10 weeks
Lid Edema, Change From Baseline
Time frame: 2 weeks
Lid Edema, Change From Baseline
Time frame: 6 weeks
Lid Edema, Change From Baseline
Time frame: 10 weeks
Lid Erythema, Change From Baseline
Time frame: 2 weeks
Lid Erythema, Change From Baseline
Time frame: 6 weeks
Lid Erythema, Change From Baseline
Time frame: 10 weeks
Lid Margin Ulceration, Change From Baseline
Time frame: 2 weeks
Lid Margin Ulceration, Change From Baseline
Time frame: 6 weeks
Lid Margin Ulceration, Change From Baseline
Time frame: 10 weeks
Conjunctival Hyperemia, Change From Baseline
Time frame: 2 weeks
Conjunctival Hyperemia, Change From Baseline
Time frame: 6 weeks
Conjunctival Hyperemia, Change From Baseline
Time frame: 10 weeks
Dryness, Change From Baseline
Time frame: 2 weeks
Dryness, Change From Baseline
Time frame: 6 weeks
Dryness, Change From Baseline
Time frame: 10 weeks
Ocular Pain, Change From Baseline
Time frame: 2 weeks
Ocular Pain, Change From Baseline
Time frame: 6 weeks
Ocular Pain, Change From Baseline
Time frame: 10 weeks
Airflow Sensitivity, Change From Baseline
Time frame: 2 weeks
Airflow Sensitivity, Change From Baseline
Time frame: 6 weeks
Airflow Sensitivity, Change From Baseline
Time frame: 10 weeks

Results and safety

Results posted to the registry on 6 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pro-ocular™	22	21
Placebo	11	11

Primary outcome: Modified SANDE Questionnaire - Frequency, Change From Baseline

Time frame: 2 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Pro-ocular™ n = 22	Placebo n = 11
Value	-22.00 (4.246)	-4.59 (6.009)

Pro-ocular™ vs Placebo: p = 0.0197, Mixed Models Analysis

Primary outcome: Corneal Fluorescein Stain - Central, Change From Baseline

Time frame: 2 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Pro-ocular™ n = 22	Placebo n = 11
Value	-0.90 (0.213)	0.20 (0.304)

Pro-ocular™ vs Placebo: p = 0.0039, Mixed Models Analysis

37 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pro-ocular™ for 2 Years	8 of 22 (36.4%)	21 of 22 (95.5%)	1 of 22
Pro-ocular™ for 10-week Masked Period Only	0 of 22 (0%)	17 of 22 (77.3%)	0 of 22
Placebo+Active for 2 Years Total	7 of 11 (63.6%)	11 of 11 (100%)	1 of 11
Placebo for 10-week Masked Period Ony	2 of 11 (18.2%)	8 of 11 (72.7%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33942724Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14.
Individual participant dataSharing planned: No. Data may be shared with other investigators.

Related trials for Chronic Ocular Graft-versus-host Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhonghui K Luo, MD, PhD principal investigator

Massachusetts Eye and Ear, Longwood

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pro-ocular™ topical gel in people with Chronic Ocular Graft-versus-host Disease, run by Glia, LLC at 1 site in United States.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Modified SANDE Questionnaire - Frequency, Change From Baseline (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT03990051, which also lists 1 linked publication.

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 6 May 2025.