Phase 2 N=33 Randomized Quadruple-blind Treatment

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

Chronic Ocular Graft-versus-host Disease

Bottom Line

View on ClinicalTrials.gov: NCT03990051 ↗

Enrolled (actual)

Serious AEs

25.8%

Results posted

May 2025

Primary outcome: Primary: Modified SANDE Questionnaire - Frequency, Change From Baseline — -22.00; -4.59 score on a scale — p=0.0197

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pro-ocular™ topical gel (Drug); Placebo topical gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Glia, LLC
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Modified SANDE Questionnaire - Frequency, Change From Baseline	-30.72; -2.18	0.0002 sig
PRIMARY Corneal Fluorescein Stain - Central, Change From Baseline	-1.18; 0.06	0.0014 sig
SECONDARY Modified SANDE Questionnaire - Frequency, Change From Baseline	-30.72; -2.18	0.0002 sig
SECONDARY Modified SANDE Questionnaire - Frequency, Change From Baseline	-30.72; -2.18	0.0002 sig
SECONDARY Corneal Fluorescein Stain - Central, Change From Baseline	-1.18; 0.06	0.0014 sig
SECONDARY Corneal Fluorescein Stain - Central, Change From Baseline	-1.18; 0.06	0.0014 sig
SECONDARY Modified SANDE Questionnaire - Global, Change From Baseline	-25.87; -1.04	0.0006 sig
SECONDARY Modified SANDE Questionnaire - Global, Change From Baseline	-25.87; -1.04	0.0006 sig
SECONDARY Modified SANDE Questionnaire - Global, Change From Baseline	-25.87; -1.04	0.0006 sig
SECONDARY Corneal Fluorescein Stain - Total, Change From Baseline	-3.97; -1.54	-3.97
SECONDARY Corneal Fluorescein Stain - Total, Change From Baseline	-3.97; -1.54	-3.97
SECONDARY Corneal Fluorescein Stain - Total, Change From Baseline	-3.97; -1.54	-3.97
SECONDARY Blurred Vision, Change From Baseline	-2.23; -0.31	0.0067 sig
SECONDARY Blurred Vision, Change From Baseline	-2.23; -0.31	0.0067 sig
SECONDARY Blurred Vision, Change From Baseline	-2.23; -0.31	0.0067 sig
SECONDARY Photophobia, Change From Baseline	-1.82; 0.01	0.0067 sig
SECONDARY Photophobia, Change From Baseline	-1.82; 0.01	0.0067 sig
SECONDARY Photophobia, Change From Baseline	-1.82; 0.01	0.0067 sig
SECONDARY Lid Edema, Change From Baseline	-1.72; -0.83	0.0155 sig
SECONDARY Lid Edema, Change From Baseline	-1.72; -0.83	0.0155 sig
SECONDARY Lid Edema, Change From Baseline	-1.72; -0.83	0.0155 sig
SECONDARY Lid Erythema, Change From Baseline	-1.42; -1.27	0.4649
SECONDARY Lid Erythema, Change From Baseline	-1.42; -1.27	0.4649
SECONDARY Lid Erythema, Change From Baseline	-1.42; -1.27	0.4649
SECONDARY Lid Margin Ulceration, Change From Baseline	-1.85; -1.27	0.1822
SECONDARY Lid Margin Ulceration, Change From Baseline	-1.85; -1.27	0.1822
SECONDARY Lid Margin Ulceration, Change From Baseline	-1.85; -1.27	0.1822
SECONDARY Conjunctival Hyperemia, Change From Baseline	-1.72; -0.99	0.083
SECONDARY Conjunctival Hyperemia, Change From Baseline	-1.72; -0.99	0.083
SECONDARY Conjunctival Hyperemia, Change From Baseline	-1.72; -0.99	0.083
SECONDARY Dryness, Change From Baseline	-3.67; -2.28	0.0435 sig
SECONDARY Dryness, Change From Baseline	-3.67; -2.28	0.0435 sig
SECONDARY Dryness, Change From Baseline	-3.67; -2.28	0.0435 sig
SECONDARY Ocular Pain, Change From Baseline	-1.86; -1.06	0.1401
SECONDARY Ocular Pain, Change From Baseline	-1.86; -1.06	0.1401
SECONDARY Ocular Pain, Change From Baseline	-1.86; -1.06	0.1401
SECONDARY Airflow Sensitivity, Change From Baseline	-1.76; -0.31	0.0389 sig
SECONDARY Airflow Sensitivity, Change From Baseline	-1.76; -0.31	0.0389 sig
SECONDARY Airflow Sensitivity, Change From Baseline	-1.76; -0.31	0.0389 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03990051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.