Long Term Follow up Dry Eye Disease
Conditions
Brief summary
The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).
Detailed description
Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease. The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
Interventions
DRUGOC-01 Low Dose, 0.12 mg/mL
OC-01 (varenicline) nasal spray
DRUGOC-01 Mid Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray
DRUGOC-01 High Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray
Placebo (vehicle) nasal spray
Sponsors
Oyster Point Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have been enrolled in the OPP-002 study 2. Have received at least one dose of the study drug/placebo in OPP-002 study 3. Completed the OPP-002 study to Visit 5 4. Have provided verbal and written informed consent
Exclusion criteria
1\. Have discontinued prior to Visit 5 in the OPP-002 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months) | Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations |
| Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months) | Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations |
| Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months) | Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations |
| Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months) | Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 29 |
| 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 | 23 |
| Placebo (Vehicle) Nasal Spray Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray | 23 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | OC-01 Mid Dose, 0.6 mg/mL | OC-01 High Dose, 1.2 mg/mL | Placebo (Vehicle) Nasal Spray | Total | OC-01 Low Dose, 0.12 mg/mL |
|---|---|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 9.25 | 69.8 years STANDARD_DEVIATION 6.64 | 63.3 years STANDARD_DEVIATION 11.38 | 67.4 years STANDARD_DEVIATION 9.51 | 67 years STANDARD_DEVIATION 9.45 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 29 participants | 23 participants | 23 participants | 101 participants | 26 participants |
| Sex: Female, Male Female | 20 Participants | 19 Participants | 16 Participants | 74 Participants | 19 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 7 Participants | 27 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 29 | 0 / 23 | 1 / 23 |
| other Total, other adverse events | 3 / 26 | 5 / 29 | 5 / 23 | 5 / 23 |
| serious Total, serious adverse events | 0 / 26 | 2 / 29 | 0 / 23 | 1 / 23 |
Outcome results
Primary
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 Mid Dose, 0.6 mg/mL | Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 High Dose, 1.2 mg/mL | Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
| Placebo (Vehicle) Nasal Spray | Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
Primary
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 Mid Dose, 0.6 mg/mL | Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 High Dose, 1.2 mg/mL | Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |
| Placebo (Vehicle) Nasal Spray | Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |
Primary
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 Mid Dose, 0.6 mg/mL | Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 High Dose, 1.2 mg/mL | Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 1 Participants |
| Placebo (Vehicle) Nasal Spray | Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations | 0 Participants |
Primary
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 Mid Dose, 0.6 mg/mL | Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |
| OC-01 High Dose, 1.2 mg/mL | Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 1 Participants |
| Placebo (Vehicle) Nasal Spray | Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations | 0 Participants |