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The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyclASol Ophthalmic Solution | Experimental | Cyclosporine A solution in vehicle |
|
| Vehicle Ophthalmic solution | Placebo Comparator | Vehicle only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyclASol topical ocular, eye drops | Drug | Cyclosporine A solution in vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining | Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst). | baseline and 1 month [day 29] |
| Change From Baseline in Eye Dryness Score | Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort. | baseline and 1 month [day 29] |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Conjunctival Lissamine Green Staining | Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. | baseline and 1 month [day 29] |
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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-004 Investigational Site | Phoenix | Arizona | 85032 | United States | ||
| CYS-004 Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37022717 | Derived | Akpek EK, Wirta DL, Downing JE, Tauber J, Sheppard JD, Ciolino JB, Meides AS, Krosser S. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmol. 2023 May 1;141(5):459-466. doi: 10.1001/jamaophthalmol.2023.0709. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CyclASol Ophthalmic Solution | Cyclosporine A solution in vehicle CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle (one drop per eye BID) |
| FG001 | Vehicle Ophthalmic Solution |
| 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 | Mar 15, 2021 |
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| Vehicle topical ocular, eye drops | Drug | Vehicle |
|
|
| Proportion of Responders in Central Corneal Fluorescein Staining Score | ≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). | baseline and 1 month [day 29] |
| Proportion of Responders in Total Corneal Fluorescein Staining Score | ≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst). | baseline and 1 month [day 29] |
| Change From Baseline in Central Corneal Fluorescein Staining | Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). | baseline and 1 month [day 29] |
| Change From Baseline in Total Corneal Fluorescein Staining | Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst). | baseline and 2 weeks [day 15] |
| Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision | Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort. | baseline and 1 month [day 29] |
| Los Angeles |
| California |
| 90013 |
| United States |
| CYS-004 Investigational Site | Newport Beach | California | 92663 | United States |
| CYS-004 Investigational Site | Santa Ana | California | 92705 | United States |
| CYS-004 Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| CYS-004 Investigational Site | Fort Lauderdale | Florida | 33309 | United States |
| CYS-004 Investigational Site | Chicago | Illinois | 60619 | United States |
| CYS-004 Investigational Site | Carmel | Indiana | 46290 | United States |
| CYS-004 Investigational Site | Indianapolis | Indiana | 46240 | United States |
| CYS-004 Investigational site | Louisville | Kentucky | 40206 | United States |
| CYS-004 Investigational Site | Andover | Massachusetts | 01810 | United States |
| CYS-004 Investigational Site | Raynham | Massachusetts | 02767 | United States |
| CYS-004 Investigational Site | Medina | Minnesota | 55364 | United States |
| CYS-004 Investigational Site | Kansas City | Missouri | 64111 | United States |
| CYS-004 Investigation Site | Kansas City | Missouri | 64154 | United States |
| CYS-004 Investigational Site | Henderson | Nevada | 89052 | United States |
| CYS-004 Investigational Site | Raleigh | North Carolina | 27603 | United States |
| CYS-004 Investigational Site | Shelby | North Carolina | 28150 | United States |
| CYS-004 Investigational Site | Fargo | North Dakota | 58103 | United States |
| CYS-004 Investigational Site | Cranberry Township | Pennsylvania | 16066 | United States |
| CYS-004 Investigational Site | Warwick | Rhode Island | 02886 | United States |
| CYS-004 Investigational Site | Memphis | Tennessee | 38119 | United States |
| CYS-004 Investigational Site | Smyrna | Tennessee | 37167 | United States |
| CYS-004 Investigational Site | Layton | Utah | 84041 | United States |
| CYS-004 Investigational site | Ogden | Utah | 84403 | United States |
| CYS-004 Investigational Site | Lynchburg | Virginia | 24502 | United States |
| CYS-004 Investigational Site | Seattle | Washington | 98119 | United States |
Vehicle only
Vehicle topical ocular, eye drops: Vehicle (one drop per eye BID)
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CyclASol Ophthalmic Solution | Cyclosporine A solution in vehicle CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle |
| BG001 | Vehicle Ophthalmic Solution | Vehicle only Vehicle topical ocular, eye drops: Vehicle |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Change From Baseline in Total Corneal Fluorescein Staining | Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst). | Posted | Least Squares Mean | Standard Error | score on a scale | baseline and 1 month [day 29] |
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| Primary | Change From Baseline in Eye Dryness Score | Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort. | Posted | Least Squares Mean | Standard Error | score on a scale | baseline and 1 month [day 29] |
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| Secondary | Change From Baseline in Total Conjunctival Lissamine Green Staining | Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. | Posted | Least Squares Mean | Standard Error | score on a scale | baseline and 1 month [day 29] |
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| Secondary | Proportion of Responders in Central Corneal Fluorescein Staining Score | ≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). | Posted | Count of Participants | Participants | baseline and 1 month [day 29] |
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| Secondary | Proportion of Responders in Total Corneal Fluorescein Staining Score | ≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst). | Posted | Count of Participants | Participants | baseline and 1 month [day 29] |
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| Secondary | Change From Baseline in Central Corneal Fluorescein Staining | Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). | Posted | Least Squares Mean | Standard Error | score on a scale | baseline and 1 month [day 29] |
|
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| Secondary | Change From Baseline in Total Corneal Fluorescein Staining | Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst). | Posted | Least Squares Mean | Standard Error | score on a scale | baseline and 2 weeks [day 15] |
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| Secondary | Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision | Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort. | Posted | Least Squares Mean | Standard Error | score on a scale | baseline and 1 month [day 29] |
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Adverse event data was were collected over the study period (29 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 | CyclASol Ophthalmic Solution | Cyclosporine A solution in vehicle CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle | 0 | 423 | 2 | 423 | 45 | 423 |
| EG001 | Vehicle Ophthalmic Solution | Vehicle only Vehicle topical ocular, eye drops: Vehicle | 0 | 411 | 3 | 411 | 37 | 411 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial Bowel Obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes Simplex Virus | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Left Foot Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation Site Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Administration site conditions |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonja Kroesser | Novaliq GmbH | +49 6221 50259 | 0 | info@novaliq.com |
| Dec 20, 2022 |
| 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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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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