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The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyclASol Ophthalmic Solution | Experimental | Cyclosporine A solution in vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyclASol Ophthalmic Solution | Drug | Cyclosporine A solution in vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Adverse Events | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Kroesser, PhD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CYS-005 Investigational Site | Los Angeles | California | 90013 | United States | ||
| CYS-005 Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38771801 | Derived | Wirta DL, Galor A, Aune CA, Vollmer PM, Liang E, Meides AS, Krosser S. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21;44(6):692-700. doi: 10.1097/ICO.0000000000003567. |
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Single arm, open label
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| ID | Title | Description |
|---|---|---|
| FG000 | CyclASol Ophthalmic Solution | Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle (one drop per eye BID). |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2020 |
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| Newport Beach |
| California |
| 92663 |
| United States |
| CYS-005 Investigational Site | Carmel | Indiana | 46290 | United States |
| CYS-005 Investigational Site | Louisville | Kentucky | 40206 | United States |
| CYS-005 Investigational Site | Andover | Massachusetts | 01810 | United States |
| CYS-005 Investigtional Site | Raynham | Massachusetts | 02767 | United States |
| CYS-005 Investigational Site | Henderson | Nevada | 89052 | United States |
| CYS-005 Investigational Site | Raleigh | North Carolina | 27603 | United States |
| CYS-005 Investigational Site | Shelby | North Carolina | 28150 | United States |
| CYS-005 Investigational Site | Fargo | North Dakota | 58103 | United States |
| CYS-005 Investigational Site | Cranberry Township | Pennsylvania | 16066 | United States |
| CYS-005 Investigational Site | Memphis | Tennessee | 38119 | United States |
| CYS-005 Investigational Site | Layton | Utah | 84041 | United States |
| CYS-005 Investigational Site | Lynchburg | Virginia | 24502 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
202 participants were enrolled. Two participants were lost to follow-up directly after Visit 1. The safety population comprised 200 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CyclASol Ophthalmic Solution | Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle |
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 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 Subjects Reporting Any Adverse Events | An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed. | Safety Analysis Set | Posted | Count of Participants | Participants | 12 months |
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|
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Data were collected over 52 weeks
Ocular and non-ocular AEs were the primary safety endpoints in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related.
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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 | CyclASol Ophthalmic Solution | Cyclosporine A solution in vehicle CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle | 0 | 200 | 4 | 200 | 13 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attach | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonja Krösser | Novaliq GmbH | +49 6221 50259 | 0 | info@novaliq.com |
| Jul 20, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|