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The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
This was a Phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 02 Nasal Spray in adult participants with dry eye disease. Approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo at Visit 1 and Visit 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | Active Comparator | 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) |
|
| 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | Active Comparator | 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) |
|
| 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) | Active Comparator | 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) |
|
| Placebo (vehicle) nasal spray | Placebo Comparator | Placebo (vehicle) nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | Drug | 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer's Test Score at Day 1 | The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome. | Day 1 (Pre to Post-Treatment Change) |
| Eye Dryness Score at Visit 2 | Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome. | Day 15 (Pre to Post-Treatment Change) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisville | Louisville | Kentucky | 40206 | United States | ||
| Andover |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35965109 | Derived | Torkildsen GL, Pattar GR, Jerkins G, Striffler K, Nau J. Efficacy and Safety of Single-dose OC-02 (Simpinicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The PEARL Phase II Randomized Trial. Clin Ther. 2022 Sep;44(9):1178-1186. doi: 10.1016/j.clinthera.2022.07.006. Epub 2022 Aug 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL) | 0.2% hemigalactarate (0.11% free base) 0.2% OC-02 Mid Dose (1.1 mg/mL) |
| FG001 | 1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL) |
| 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 | Oct 11, 2017 | Sep 28, 2021 |
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| 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | Drug | 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) |
|
| 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) | Drug | 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) |
|
| Placebo (vehicle) nasal spray | Drug | Placebo (vehicle) nasal spray |
|
| Andover |
| Massachusetts |
| 01810 |
| United States |
| Nashville | Nashville | Tennessee | 37210 | United States |
1% hemigalactarate (0.11% free base)
1% OC-02 Mid Dose (5.5 mg/mL)
| FG002 | 2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL) | 2% hemigalactarate (0.11% free base) 2% OC-02 High Dose (11.1 mg/mL) |
| 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 | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) |
| BG001 | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) |
| BG002 | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) |
| 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/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Schirmer's Test Score at Day 1 | The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome. | Subjects in the ITT population | Posted | Least Squares Mean | 95% Confidence Interval | mm | Day 1 (Pre to Post-Treatment Change) |
|
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| Primary | Eye Dryness Score at Visit 2 | Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome. | Subjects in the ITT Population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics | Posted | Least Squares Mean | 95% Confidence Interval | mm | Day 15 (Pre to Post-Treatment Change) |
|
Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
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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 | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 0 | 41 | 1 | 41 | 17 | 41 |
| EG001 | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 0 | 41 | 0 | 41 | 23 | 41 |
| EG002 | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 0 | 41 | 0 | 41 | 24 | 41 |
| EG003 | Placebo (Vehicle) Nasal Spray | Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray | 0 | 42 | 0 | 42 | 4 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| failure to thrive | Metabolism and nutrition disorders | Medra Version 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | Medra Version 20.1 | Systematic Assessment |
| |
| Keratits | Eye disorders | Medra Version 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Medra Version 20.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Medra Version 20.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Medra Version 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Medra Version 20.1 | Systematic Assessment |
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| Instillation site irritation | General disorders | Medra Version 20.1 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | Medra Version 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | Medra Version 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | Medra Version 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | Medra Version 20.1 | Systematic Assessment |
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| Tympanic membrane perforation | Ear and labyrinth disorders | Medra Version 20.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Medra Version 20.1 | Systematic Assessment |
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| Gastrooesphageal reflux disease | Gastrointestinal disorders | Medra Version 20.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Medra Version 20.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | Medra Version 20.1 | Systematic Assessment |
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| Acute stress disorder | Psychiatric disorders | Medra Version 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Medra Version 20.1 | 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 | May 10, 2018 | Sep 28, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Not Hispanic/Latino |
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| Not reported |
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| Asian |
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| Black/African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Multiple races |
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| Other |
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Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray |
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