Trial Outcomes & Findings for Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (NCT NCT03920215)
NCT ID: NCT03920215
Last Updated: 2023-11-01
Results Overview
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
101 participants
Primary outcome timeframe
6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
OC-01 Low Dose, 0.12 mg/mL
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
29
|
23
|
23
|
|
Overall Study
COMPLETED
|
25
|
27
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
OC-01 Low Dose, 0.12 mg/mL
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=26 Participants
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=29 Participants
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=23 Participants
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 9.45 • n=26 Participants
|
68.9 years
STANDARD_DEVIATION 9.25 • n=29 Participants
|
69.8 years
STANDARD_DEVIATION 6.64 • n=23 Participants
|
63.3 years
STANDARD_DEVIATION 11.38 • n=23 Participants
|
67.4 years
STANDARD_DEVIATION 9.51 • n=101 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=26 Participants
|
20 Participants
n=29 Participants
|
19 Participants
n=23 Participants
|
16 Participants
n=23 Participants
|
74 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=26 Participants
|
9 Participants
n=29 Participants
|
4 Participants
n=23 Participants
|
7 Participants
n=23 Participants
|
27 Participants
n=101 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
29 participants
n=29 Participants
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
101 participants
n=101 Participants
|
PRIMARY outcome
Timeframe: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)Population: Subjects in the ITT population
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Outcome measures
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=26 Participants
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=29 Participants
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=23 Participants
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)Population: Subjects in the ITT population
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Outcome measures
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=26 Participants
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=29 Participants
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=23 Participants
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)Population: Subjects in the ITT population (subjects with non-missing data).
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Outcome measures
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=25 Participants
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=27 Participants
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=22 Participants
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)Population: Subjects in the ITT population (subjects with non-missing data)
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Outcome measures
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=25 Participants
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=27 Participants
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 Participants
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=22 Participants
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
OC-01 Low Dose, 0.12 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OC-01 Mid Dose, 0.6 mg/mL
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
OC-01 High Dose, 1.2 mg/mL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Vehicle) Nasal Spray
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=26 participants at risk
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=29 participants at risk
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 participants at risk
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=23 participants at risk
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
Other adverse events
| Measure |
OC-01 Low Dose, 0.12 mg/mL
n=26 participants at risk
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 Low Dose, 0.12 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 Mid Dose, 0.6 mg/mL
n=29 participants at risk
OC-01 (varenicline) nasal spray, 0.62 mg/mL
OC-01 Mid Dose, 0.6 mg/mL: OC-01 (varenicline) nasal spray
|
OC-01 High Dose, 1.2 mg/mL
n=23 participants at risk
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL: OC-01 (varenicline) nasal spray
|
Placebo (Vehicle) Nasal Spray
n=23 participants at risk
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Eye disorders
Cataract
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Eye disorders
Eye pain
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Eye disorders
Open angle glaucoma
|
3.8%
1/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
General disorders
Instillation site pruritis
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Product Issues
Device (IOL) dislocation
|
3.8%
1/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
3.8%
1/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
3.4%
1/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
8.7%
2/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/29 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
0.00%
0/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
4.3%
1/23 • 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place