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This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 Cohort 1 | Other | Vehicle administered to study eye and Sham administered to non-study eye on Day 1. |
|
| Stage 1 Cohort 2 | Experimental | Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. |
|
| Stage 1 Cohort 3 | Experimental | Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. |
|
| Stage 1 Cohort 4 | Experimental | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. |
|
| Stage 1 Cohort 5A | Experimental | Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle | Drug | Vehicle of cyclosporine administered as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug. | First dose of study drug to up to 24 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining Score Using a 6-Point Scale | Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement). Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleonora Safyan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| Lugene Eye Institute |
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| Label | URL |
|---|---|
| More Information | View source |
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This study was terminated. Stage 2 of the study was not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 Cohort 5A | Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. |
| FG001 | Stage 1 Cohort 4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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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 | Jan 19, 2017 | Apr 12, 2018 |
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| Stage 1 Cohort 6A | Experimental | Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. |
|
| Stage 1 Cohort 6B | Experimental | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. |
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| Stage 1 Cohort 6C | Experimental | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
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| Stage 1 Cohort 6D | Experimental | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
|
| Sham | Other | Sham administered to non-study eye as per protocol on Day 1 |
|
| Cyclosporine New Ophthalmic Formulation | Drug | Cyclosporine New Ophthalmic Formulation administered as per protocol |
|
|
| Baseline (Day 1) to Week 12 |
| Glendale |
| California |
| 91204 |
| United States |
| Lakeside Vision Center | Irvine | California | 92604 | United States |
| Steve Yoelin MD Medical Asscociates | Newport Beach | California | 92663 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Vision Institute | Colorado Springs | Colorado | 80907 | United States |
| Johns Hopkins University - Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
| Eye Centers of Racine and Kenosha | Kenosha | Wisconsin | 53142 | United States |
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
| FG002 | Stage 1 Cohort 6C | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
| FG003 | Stage 1 Cohort 3 | Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. |
| FG004 | Stage 1 Cohort 2 | Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. |
| FG005 | Stage 1 Cohort 6B | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. |
| FG006 | Stage 1 Cohort 6D | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
| FG007 | Stage 1 Cohort 6A | Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. |
| FG008 | Stage 1 Cohort 1 | Vehicle administered to study eye and Sham administered to non-study eye on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
Safety Population included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 Cohort 5A | Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. |
| BG001 | Stage 1 Cohort 4 | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. |
| BG002 | Stage 1 Cohort 6C | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
| BG003 | Stage 1 Cohort 3 | Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. |
| BG004 | Stage 1 Cohort 2 | Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. |
| BG005 | Stage 1 Cohort 6B | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. |
| BG006 | Stage 1 Cohort 6D | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
| BG007 | Stage 1 Cohort 6A | Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. |
| BG008 | Stage 1 Cohort 1 | Vehicle administered to study eye and Sham administered to non-study eye on Day 1. |
| BG009 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug. | Safety Population included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug to up to 24 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Corneal Staining Score Using a 6-Point Scale | Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement). Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint. | Modified Intent-to-treat (mITT) Population included all participant who received study treatment and had Baseline and at least 1 post-baseline assessment. Analyses includes participants who had data at both Baseline and Week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to Week 12 |
|
|
First dose of study drug to up to 24 Weeks
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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 | Stage 1 Cohort 5A | Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG001 | Stage 1 Cohort 4 | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. | 0 | 8 | 1 | 8 | 8 | 8 |
| EG002 | Stage 1 Cohort 6C | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Stage 1 Cohort 3 | Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG004 | Stage 1 Cohort 2 | Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG005 | Stage 1 Cohort 6B | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG006 | Stage 1 Cohort 6D | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG007 | Stage 1 Cohort 6A | Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG008 | Stage 1 Cohort 1 | Vehicle administered to study eye and Sham administered to non-study eye on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenopia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Corneal deposits | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
| |
| Meibomian gland discharge | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctival abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Antinuclear antibody positive | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2017 | Apr 12, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| 45 to 65 years |
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| >65 years |
|
| Male |
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| Black |
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| Asian |
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| Hispanic |
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