Trial Outcomes & Findings for Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease (NCT NCT03591874)
NCT ID: NCT03591874
Last Updated: 2022-07-06
Results Overview
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.
TERMINATED
PHASE3
59 participants
Baseline, Day 84
2022-07-06
Participant Flow
Participant milestones
| Measure |
OCU-300
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye, two times per day (BID)
|
Placebo
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
19
|
|
Overall Study
Received at Least 1 Study Treatment
|
29
|
16
|
|
Overall Study
COMPLETED
|
21
|
12
|
|
Overall Study
NOT COMPLETED
|
19
|
7
|
Reasons for withdrawal
| Measure |
OCU-300
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye, two times per day (BID)
|
Placebo
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Investigator Withdrawal of Subject
|
1
|
0
|
|
Overall Study
On Study at Time of Study Termination
|
12
|
6
|
Baseline Characteristics
Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Baseline characteristics by cohort
| Measure |
OCU-300
n=29 Participants
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye BID
|
Placebo
n=16 Participants
One drop of ophthalmic buffered saline administered in each eye BID
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 13.91 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 7.74 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 84Population: 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
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.
Outcome measures
| Measure |
OCU-300
n=28 Participants
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye BID
|
Placebo
n=13 Participants
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
Baseline
|
52.23 score on a scale
Standard Deviation 9.238
|
51.92 score on a scale
Standard Deviation 11.821
|
|
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
Day 84
|
34.88 score on a scale
Standard Deviation 14.652
|
37.71 score on a scale
Standard Deviation 19.378
|
|
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
Change from Baseline to Day 84
|
-17.62 score on a scale
Standard Deviation 14.086
|
-13.96 score on a scale
Standard Deviation 14.161
|
PRIMARY outcome
Timeframe: Baseline, Day 84Population: 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
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).
Outcome measures
| Measure |
OCU-300
n=28 Participants
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye BID
|
Placebo
n=13 Participants
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score
Baseline
|
6.2 score on a scale
Standard Deviation 1.77
|
6.5 score on a scale
Standard Deviation 1.85
|
|
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score
Day 84
|
4.8 score on a scale
Standard Deviation 2.86
|
4.1 score on a scale
Standard Deviation 3.67
|
|
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score
Change from Baseline to Day 84
|
-1.8 score on a scale
Standard Deviation 3.33
|
-2.6 score on a scale
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: Baseline, Day 84Population: 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
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.
Outcome measures
| Measure |
OCU-300
n=28 Participants
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye BID
|
Placebo
n=13 Participants
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores
Baseline
|
74.4 score on a scale
Standard Deviation 18.97
|
69.1 score on a scale
Standard Deviation 21.90
|
|
Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores
Day 84
|
50.5 score on a scale
Standard Deviation 24.05
|
44.1 score on a scale
Standard Deviation 36.43
|
|
Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores
Change from Baseline to Day 84
|
-26.5 score on a scale
Standard Deviation 22.24
|
-26.6 score on a scale
Standard Deviation 27.50
|
Adverse Events
OCU-300
Placebo
Serious adverse events
| Measure |
OCU-300
n=29 participants at risk
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye BID
|
Placebo
n=16 participants at risk
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/29 • Day 1 (post-dose) up to 84 Days
|
6.2%
1/16 • Day 1 (post-dose) up to 84 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
1/29 • Day 1 (post-dose) up to 84 Days
|
0.00%
0/16 • Day 1 (post-dose) up to 84 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Day 1 (post-dose) up to 84 Days
|
0.00%
0/16 • Day 1 (post-dose) up to 84 Days
|
|
Cardiac disorders
Coronary artery disease
|
3.4%
1/29 • Day 1 (post-dose) up to 84 Days
|
0.00%
0/16 • Day 1 (post-dose) up to 84 Days
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
1/29 • Day 1 (post-dose) up to 84 Days
|
0.00%
0/16 • Day 1 (post-dose) up to 84 Days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Day 1 (post-dose) up to 84 Days
|
6.2%
1/16 • Day 1 (post-dose) up to 84 Days
|
Other adverse events
| Measure |
OCU-300
n=29 participants at risk
One drop of Brimonidine Tartrate Nanoemulsion 0.18% administered in each eye BID
|
Placebo
n=16 participants at risk
One drop of ophthalmic buffered saline administered in each eye BID
|
|---|---|---|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Day 1 (post-dose) up to 84 Days
|
6.2%
1/16 • Day 1 (post-dose) up to 84 Days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Day 1 (post-dose) up to 84 Days
|
6.2%
1/16 • Day 1 (post-dose) up to 84 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/29 • Day 1 (post-dose) up to 84 Days
|
6.2%
1/16 • Day 1 (post-dose) up to 84 Days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/29 • Day 1 (post-dose) up to 84 Days
|
6.2%
1/16 • Day 1 (post-dose) up to 84 Days
|
Additional Information
Vijay Tammara, VP, Strategic Regulatory Operations
Ocugen
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place