Trial Outcomes & Findings for Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease (NCT NCT03414645)

Last Updated: 2026-06-12

Results Overview

To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: Percentage of patients in each dose group with ocular adverse events at Day 42

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

64 participants

Primary outcome timeframe

42 Days

Results posted on

2026-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	CAM-101 10% FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Overall Study STARTED	20	22	22
Overall Study COMPLETED	19	22	21
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CAM-101 10% FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Overall Study Adverse Event	0	0	1
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle Control n=22 Participants PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop	Total n=64 Participants Total of all reporting groups	CAM-101 10% n=20 Participants FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 Participants FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate
Age, Categorical <=18 years	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=9 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=267 Participants	64 Participants n=265 Participants	20 Participants n=9 Participants	22 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=9 Participants	0 Participants n=27 Participants
Age, Continuous	53.1 years STANDARD_DEVIATION 13.8 • n=267 Participants	53.4 years STANDARD_DEVIATION 13.8 • n=265 Participants	53.6 years STANDARD_DEVIATION 14.9 • n=9 Participants	53.7 years STANDARD_DEVIATION 13.5 • n=27 Participants
Sex: Female, Male Female	11 Participants n=267 Participants	28 Participants n=265 Participants	7 Participants n=9 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=267 Participants	36 Participants n=265 Participants	13 Participants n=9 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=267 Participants	11 Participants n=265 Participants	5 Participants n=9 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=267 Participants	52 Participants n=265 Participants	15 Participants n=9 Participants	19 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=267 Participants	1 Participants n=265 Participants	0 Participants n=9 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=9 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=267 Participants	2 Participants n=265 Participants	1 Participants n=9 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=9 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=267 Participants	3 Participants n=265 Participants	2 Participants n=9 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	20 Participants n=267 Participants	55 Participants n=265 Participants	15 Participants n=9 Participants	20 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=9 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=267 Participants	4 Participants n=265 Participants	2 Participants n=9 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 42 Days

Population: All Treated patients

Outcome measures

Outcome measures
Measure	CAM-101 10% n=20 Participants FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 Participants FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 Participants PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Number of Participants With Ocular Treatment-related Adverse Events as Assessed by CTCAE v4.0	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 42 Days

Number of participants with systemic treatment-related adverse events as assessed by CTCAE v4.0 To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: Percentage of patients in each dose group with systemic adverse event at Day 42

Outcome measures

Outcome measures
Measure	CAM-101 10% n=20 Participants FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 Participants FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 Participants PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Number of Participants With Systemic Treatment-related Adverse Events as Assessed by CTCAE v4.0	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 42 Days

To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: The percentage of patients in each dose group that show a change from Normal to Abnormal with clinical significance in any ocular examination assessment at Day 42

Outcome measures

Outcome measures
Measure	CAM-101 10% n=20 Participants FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 Participants FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 Participants PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Number of Participants With Treatment-related Adverse Events as Assessed Change From Normal to Abnormal With Clinical Significance in Any Ocular Examination	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 42 Days

Population: Comparison of change for treated subjects from baseline to day 42 between treatments in the double masked treatment phase

The OSDI is a 12-item validated questionnaire used to assess the severity of dry eye disease symptoms and their impact on vision-related function. The questionnaire comprises three subscales: ocular symptoms, vision-related function, and environmental triggers. Each item is scored on a 5-point scale (0 = none of the time; 4 = all of the time). The total OSDI score is calculated using the following formula: OSDI score = (sum of score for all questions answered × 25) ÷ number of questions answered; Scores range from 0 to 100; higher scores indicate greater ocular surface disease severity and disability (0-12: normal; 13-22: mild disease; 23-32: moderate disease; \>33: severe disease).

Outcome measures

Outcome measures
Measure	CAM-101 10% n=20 Participants FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 Participants FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 Participants PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Efficacy as Measured by Ocular Surface Disease Index (OSDI)	-14.86 score on a scale Interval -25.32 to -4.39	-19.71 score on a scale Interval -31.28 to -8.14	-10.83 score on a scale Interval -22.22 to 0.57

SECONDARY outcome

Timeframe: 42 Days

To evaluate the preliminary efficacy of two concentrations of FD hPL (10 vol/vol % and 30 vol/vol %) to each other and to a vehicle control in the treatment of patients with DED secondary to GvHD as the result of allogeneic stem cell transplantation as measured by ocular discomfort using the 100 point visual analogue scale (VAS) scores Change from baseline in ocular discomfort score as measured with VAS on Day 42VAS Patients will be asked questions about their current ocular discomfort by indicating from 0 (no discomfort) to 100 (maximal discomfort)

Outcome measures

Outcome measures
Measure	CAM-101 10% n=20 Participants FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 Participants FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 Participants PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Efficacy as Measured by Ocular Discomfort Using the 100 Point Visual Analogue Scale (VAS) Scores	-11.44 score on a scale Interval -26.38 to 3.51	-20.73 score on a scale Interval -36.98 to -4.49	-2.70 score on a scale Interval -18.69 to 13.29

Adverse Events

CAM-101 10%

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

CAM-101 30%

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Vehicle Control

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CAM-101 10% n=20 participants at risk FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 participants at risk FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 participants at risk PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Blood and lymphatic system disorders febrile neutropenia	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Infections and infestations Periorbital Cellulitis	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Cardiac disorders hypertrophic cardiomyopathy	0.00% 0/20 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Infections and infestations Pneumonia	0.00% 0/20 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	9.1% 2/22 • Number of events 2 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Infections and infestations Respiratory Syncytial Virus	0.00% 0/20 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Nervous system disorders Dysphasia	0.00% 0/20 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.

Other adverse events

Other adverse events
Measure	CAM-101 10% n=20 participants at risk FD hPL 10 vol/vol % CAM-101 10%: fibrinogen-depleted human platelet lysate	CAM-101 30% n=22 participants at risk FD hPL 30 vol/vol % CAM-101 30%: fibrinogen-depleted human platelet lysate	Vehicle Control n=22 participants at risk PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Vehicle Control: PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
Eye disorders photophobia	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Eye disorders pain	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	9.1% 2/22 • Number of events 3 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Eye disorders Eye irritation	5.0% 1/20 • Number of events 2 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	13.6% 3/22 • Number of events 4 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Eye disorders dry eye	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	9.1% 2/22 • Number of events 2 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
General disorders Pain	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
General disorders Pyrexia	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 2 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Investigations Increased Intraocular Pressure	10.0% 2/20 • Number of events 2 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	0.00% 0/22 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	5.0% 1/20 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	18.2% 4/22 • Number of events 4 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.	4.5% 1/22 • Number of events 1 • The AE/SAE reporting period starts from the day the patient signs the informed consent document until the end of the treatment period (Day 42) or 30 days after the last dose of Investigational Product, whichever occurs last, up to 72 days. All AEs will be monitored and recorded for the progress of the event until they resolve or reach a clinically stable outcome, or until it has been determined that the study treatment or participation is not the cause.

Additional Information

Dr. Neera Jagirdar

Cambium Medical Technologies

Phone: 6175929138

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place