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To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-CSI-Cohort 1 | Experimental | Formulation 2A-.36 mg |
|
| OTX-CSI-Cohort 2 | Experimental | Formulation 1- .36 mg |
|
| HV | Placebo Comparator | Cohort 2: Formulation 2B |
|
| OTX-CSI- Cohort 2 | Experimental | Formulation 2A- .36 mg |
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| HV-2 | Placebo Comparator | Cohort 2: Formulation 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-CSI | Drug | OTX-CSI intracanalicular insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | From Screening to Study Exit, approximately 156 days. |
| Schirmer Test Score, CFB at Week 12 | A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm). | Change from Baseline at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Therapeutix, Inc. | Garden Grove | California | 92843 | United States | ||
| Ocular Therapeutix, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-CSI Cohort 1 F2A | This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months) |
| FG001 | OTX-CSI Cohort 2 F1 |
| 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 | Jun 3, 2021 | Oct 27, 2022 |
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Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
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| Placebo Vehicle | Other | Hydrogel Vehicle intracanalicular insert |
|
| Inglewood |
| California |
| 90301 |
| United States |
| Ocular Therapeutix, Inc. | Mission Hills | California | 91345 | United States |
| Ocular Therapeutix, Inc. | Delray Beach | Florida | 33484 | United States |
| Ocular Therapeutix, Inc. | Largo | Florida | 33773 | United States |
| Ocular Therapeutix, Inc. | Lake Villa | Illinois | 60046 | United States |
| Ocular Therapeutix, Inc. | Kansas City | Missouri | 64111 | United States |
| Ocular Therapeutix, Inc | St Louis | Missouri | 63128 | United States |
| Ocular Therapeutix | St Louis | Missouri | 63131 | United States |
| Ocular Therapeutix, Inc. | Cleveland | Ohio | 44115 | United States |
| Ocular Therapeutix, Inc. | Cranberry Township | Pennsylvania | 16066 | United States |
| Ocular Therapeutix, Inc. | Memphis | Tennessee | 38119 | United States |
| Ocular Therapeutix, Inc. | El Paso | Texas | 79902 | United States |
| Ocular Therapeutix | Lakeway | Texas | 78738 | United States |
| Ocular Therapeutix, Inc. | Murray | Utah | 84107 | United States |
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
| FG002 | OTX-CSI Cohort 2 F2A | Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months) |
| FG003 | OTX-CSI Cohort 2 F2B | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months) |
| FG004 | OTX-CSI Cohort 2 F3 | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-CSI Cohort 1 F2A | This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months) |
| BG001 | OTX-CSI Cohort 2 F1 | Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months) |
| BG002 | OTX-CSI Cohort 2 F2A | Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months) |
| BG003 | OTX-CSI Cohort 2 F2B | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months) |
| BG004 | OTX-CSI Cohort 2 F3 | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week) |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye). | Count of Participants | Participants |
| ||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye). | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye). | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye). | Number | 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 | Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | Posted | Number | count of participants | From Screening to Study Exit, approximately 156 days. |
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| Primary | Schirmer Test Score, CFB at Week 12 | A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm). | Cohort 1 was not included in this analysis, as Cohort 1 was evaluated for Safety only. | Posted | Least Squares Mean | 95% Confidence Interval | millimeters | Change from Baseline at Week 12 |
|
approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
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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 | OTX-CSI Cohort 1 F2A | This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months) | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | OTX-CSI Cohort 2 F1 | Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months) | 0 | 42 | 1 | 42 | 15 | 42 |
| EG002 | OTX-CSI Cohort 2 F2A | Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months) | 0 | 41 | 2 | 41 | 14 | 41 |
| EG003 | OTX-CSI Cohort 2 F2B | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months) | 0 | 43 | 0 | 43 | 5 | 43 |
| EG004 | OTX-CSI Cohort 2 F3 | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week) | 0 | 22 | 0 | 22 | 1 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hiatus Hernia | Gastrointestinal disorders | Non-systematic Assessment |
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| COVID-19 Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Oral Herpes | Infections and infestations | Non-systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Candida Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Ocular Therapeutix | 781-357-4000 | clinicalaffairs@ocutx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2021 | Oct 27, 2022 | 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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| OG004 | OTX-CSI Cohort 2 F3 | Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week) |
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