Trial · NCT03591874

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

NCT03591874, Phase 3, Terminated, Ocugen; results first posted 2022-07-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease. Trials, record NCT03591874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03591874

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
NCT number: NCT03591874
Status: Terminated
Phases: Phase 3
Enrollment: 59 participants, actual
Lead sponsor: Ocugen
Conditions: Graft Versus Host Disease, Ocular Surface Disease, oGVHD, Ocular Graft vs Host Disease, Brimonidine Tartrate, Lubricant Eye Drops, Ophthalmic Solutions, Graft vs Host Disease
Interventions: Brimonidine Tartrate, Placebos
First posted: 2018-07-19
Last updated: 2022-07-06
Results first posted: 2022-07-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	Baseline, Day 84	The VBR consists of a set of ten images illustrating different degrees of ocular redness, ranging from normal to severe, and each image is assigned a value from 10 (least redness) to 100 (most redness). The bulbar conjunctival injection of the participant's eye (nasal and temporal) was examined via slit-lamp examination and compared to the reference images in the VBR and graded accordingly.
Primary	Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score	Baseline, Day 84	Participants were asked to rate their worst ocular pain/discomfort in the preceding 24 hours using a 10-point scale ranging from "None" (score=0) to "Unbearable/Excruciating" (score=10).
Secondary	Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores	Baseline, Day 84	The SANDE questionnaire is a short VAS assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100, with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	Baseline, Day 84	The Intention-To-Treat (ITT) set included all randomized participants. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point	score on a scale	MEAN
PRIMARY	Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score	Baseline, Day 84	The ITT set included all randomized participants. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point	score on a scale	MEAN
SECONDARY	Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores	Baseline, Day 84	The ITT set included all randomized participants. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	OCU-300	Baseline	52.23	Standard Deviation 9.238	score on a scale
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	Placebo	Baseline	51.92	Standard Deviation 11.821	score on a scale
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	OCU-300	Day 84	34.88	Standard Deviation 14.652	score on a scale
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	Placebo	Day 84	37.71	Standard Deviation 19.378	score on a scale
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	OCU-300	Change from Baseline to Day 84	-17.62	Standard Deviation 14.086	score on a scale
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score	Placebo	Change from Baseline to Day 84	-13.96	Standard Deviation 14.161	score on a scale
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score	OCU-300	Baseline	6.2	Standard Deviation 1.77	score on a scale
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score	Placebo	Baseline	6.5	Standard Deviation 1.85	score on a scale
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score	OCU-300	Day 84	4.8	Standard Deviation 2.86	score on a scale
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score	Placebo	Day 84	4.1	Standard Deviation 3.67	score on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	OCU-300	40
Overall Study	STARTED	Placebo	19
Overall Study	Received at Least 1 Study Treatment	OCU-300	29
Overall Study	Received at Least 1 Study Treatment	Placebo	16
Overall Study	COMPLETED	OCU-300	21
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	OCU-300	19
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Influenza	Infections and infestations	OCU-300	1	29
other	Influenza	Infections and infestations	Placebo	1	16
other	Pneumonia	Infections and infestations	OCU-300	0	29
other	Pneumonia	Infections and infestations	Placebo	1	16
other	Cough	Respiratory, thoracic and mediastinal disorders	OCU-300	0	29
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	1	16
other	Dry mouth	Gastrointestinal disorders	OCU-300	0	29
other	Dry mouth	Gastrointestinal disorders	Placebo	1	16
serious	Gastrointestinal infection	Infections and infestations	OCU-300	0	29
serious	Gastrointestinal infection	Infections and infestations	Placebo	1	16

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OCU-300	0	29
Total, all-cause mortality	Placebo	0	16
Total, other adverse events	OCU-300	1	29
Total, other adverse events	Placebo	4	16
Total, serious adverse events	OCU-300	2	29
Total, serious adverse events	Placebo	1	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
OCU-300 vs Placebo: deaths from any cause	Trial comparisons
OCU-300 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03591874

GET https://conductscience.org/api/trials/v1/NCT03591874/registered

API reference For AI assistants