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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Active Comparator | OC-01 (varenicline) nasal spray, 0.12 mg/mL |
|
| OC-01 Mid Dose, 0.6 mg/mL | Active Comparator | OC-01 (varenicline) nasal spray, 0.60 mg/mL |
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| OC-01 High Dose, 1.2 mg/mL | Active Comparator | OC-01 (varenicline) nasal spray, 1.2 mg/mL |
|
| Placebo (vehicle) nasal spray | Placebo Comparator | Placebo (vehicle) nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Drug | OC-01 (varenicline) nasal spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 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 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 | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
1. Have discontinued prior to Visit 5 in the OPP-002 study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | Newport Beach | California | 92663 | United States | ||
| Indianapolis |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2019 | Sep 10, 2021 |
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| OC-01 Mid Dose, 0.6 mg/mL | Drug | OC-01 (varenicline) nasal spray |
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| OC-01 High Dose, 1.2 mg/mL | Drug | OC-01 (varenicline) nasal spray |
|
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| Placebo (vehicle) nasal spray | Drug | Placebo (vehicle) nasal spray |
|
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| Andover | Andover | Massachusetts | 01810 | United States |
| FG002 | 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 |
| FG003 | Placebo (Vehicle) Nasal Spray | Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray |
| COMPLETED |
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| NOT COMPLETED |
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Subjects in the ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Placebo (Vehicle) Nasal Spray | Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Subjects in the ITT population | Posted | Count of Participants | Participants | 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months) |
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| 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 | Subjects in the ITT population | Posted | Count of Participants | Participants | 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months) |
| |||||||||||||||||||||||||||||||||||||
| 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 | Subjects in the ITT population (subjects with non-missing data). | Posted | Count of Participants | Participants | 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months) |
| |||||||||||||||||||||||||||||||||||||
| 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 | Subjects in the ITT population (subjects with non-missing data) | Posted | Count of Participants | Participants | 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months) |
|
12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 26 | 0 | 26 | 3 | 26 |
| EG001 | 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 | 0 | 29 | 2 | 29 | 5 | 29 |
| EG002 | 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 | 0 | 23 | 0 | 23 | 5 | 23 |
| EG003 | Placebo (Vehicle) Nasal Spray | Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray | 1 | 23 | 1 | 23 | 5 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 20.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival oedema | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Corneal erosion | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Open angle glaucoma | Eye disorders | MedDra 20.0 | Systematic Assessment |
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| Instillation site pruritis | General disorders | MedDra 20.0 | Systematic Assessment |
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| Device (IOL) dislocation | Product Issues | MedDra 20.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
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| Oesophageal disorder | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
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| Varices oesophageal | Gastrointestinal disorders | MedDra 20.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDra 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
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| Plantar fascitis | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | MedDra 20.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDra 20.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDra 20.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDra 20.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDra 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Nau | Oyster Point Pharma, Inc. | 609-382-9035 | jnau@oysterpointrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2019 | Sep 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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