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| Name | Class |
|---|---|
| Oyster Point Pharma, Inc. | INDUSTRY |
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This study will investigate how well OC-01 (varenicline) nasal spray can treat the signs and symptoms of dry eye disease in those Sjogren's Syndrome. Patients at least 18 years old with moderate-to-severe Sjogren's dry eye disease may be eligible for this study. If you are eligible to participate in the study and you decide to join, there will be 3 study visits over approximately 1 month. You will also self-administer the nasal spray at home every day, 2 times a day during this month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC-01 (varenicline solution) 0.03 mg nasal spray | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline Nasal Spray | Drug | OC-01 (varenicline solution) 0.03 mg nasal spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Cornea Staining | The National Eye Institute (NEI) scale is the method that will be used to measure corneal staining using fluorescein strips on a scale of 0-3. The scale is a density-based scoring from 0-3 with 0 indicating no staining and 3 indicating highest density of staining. | Baseline to Day 28 |
| Mean Change in Eye Dryness Score as Measured by the Visual Analogue Scale (VAS) | VAS is a validated, subjective measure for acute and chronic pain. Patients rate eye dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." | Baseline to Day 28 |
| Mean Change in Conjunctival Staining | The Van Bijsterveld and Utrecht scale is the method that will be used to measure conjunctival staining while using lissamine green dye. The scale is a from 0-3 with 0 indicating no staining and 3 indicating confluent staining. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity | LogMAR or Logarithm of the Minimum Angle of Resolution was the method used for measuring best correct visual acuity (BCVA). LogMAR is a scale from -0.2 to 1.6 where the letter size is described in LogMAR units such that LogMAR -0.2 is equivalent to 20/12 (best vision) and LogMAR 1.6 is equivalent to 20/800 (Worse vision). The letter size change in units of 0.1 LogMAR from one row to the next. |
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Inclusion Criteria:
Exclusion Criteria:
Have undergone previous ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scheie Eye Institute at the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40166690 | Derived | Gupta AS, Linaburg TJ, Iacobucci E, Augello PA, Qin VL, Ying GS, Bunya VY, Massaro M. Varenicline Solution Nasal Spray for the Treatment of Dry Eye Disease in Sjogren's Disease: A Pilot Study. Clin Ophthalmol. 2025 Mar 27;19:1073-1084. doi: 10.2147/OPTH.S512364. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OC-01 (Varenicline Solution) 0.03 mg Nasal Spray | Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray every 12 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OC-01 (Varenicline Solution) 0.03 mg Nasal Spray | Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Change in Cornea Staining | The National Eye Institute (NEI) scale is the method that will be used to measure corneal staining using fluorescein strips on a scale of 0-3. The scale is a density-based scoring from 0-3 with 0 indicating no staining and 3 indicating highest density of staining. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Day 28 |
|
|
Adverse Events were collected over the 1 month of each participants enrollment.
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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 (Varenicline Solution) 0.03 mg Nasal Spray | Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ophthalmology Clinical Research | Scheie Eye Institute | 215-662-8038 | ophth.clinicalresearch@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 | Jul 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Baseline to Day 28 |
| Mean Change in Dry Mouth Scale | VAS is a validated, subjective measure for acute and chronic pain. Patients rate mouth dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." | Baseline to Day 28 |
| Mean Change in Nose Dryness Scale | VAS is a validated, subjective measure for acute and chronic pain. Patients rate nose dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." | Baseline to Day 28 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Mean Change in Eye Dryness Score as Measured by the Visual Analogue Scale (VAS) | VAS is a validated, subjective measure for acute and chronic pain. Patients rate eye dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Day 28 |
|
|
|
| Primary | Mean Change in Conjunctival Staining | The Van Bijsterveld and Utrecht scale is the method that will be used to measure conjunctival staining while using lissamine green dye. The scale is a from 0-3 with 0 indicating no staining and 3 indicating confluent staining. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Day 28 |
|
|
|
| Secondary | Mean Change in Best Corrected Visual Acuity | LogMAR or Logarithm of the Minimum Angle of Resolution was the method used for measuring best correct visual acuity (BCVA). LogMAR is a scale from -0.2 to 1.6 where the letter size is described in LogMAR units such that LogMAR -0.2 is equivalent to 20/12 (best vision) and LogMAR 1.6 is equivalent to 20/800 (Worse vision). The letter size change in units of 0.1 LogMAR from one row to the next. | Posted | Mean | 95% Confidence Interval | logMAR | Baseline to Day 28 |
|
|
|
| Secondary | Mean Change in Dry Mouth Scale | VAS is a validated, subjective measure for acute and chronic pain. Patients rate mouth dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Day 28 |
|
|
|
| Secondary | Mean Change in Nose Dryness Scale | VAS is a validated, subjective measure for acute and chronic pain. Patients rate nose dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort." | Posted | Mean | 97.5% Confidence Interval | units on a scale | Baseline to Day 28 |
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| 0 |
| 39 |
| 0 |
| 39 |
| 22 |
| 39 |
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| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |