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This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclosporine ophthalmic emulsion Formulation A (Formulation A) | Experimental | Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A |
|
| cyclosporine ophthalmic emulsion Formulation B (Formulation B) | Experimental | PGP: cyclosporine ophthalmic emulsion Formulation B |
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| Formulation A and cyclosporine ophthalmic emulsion 0.05% | Other | Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% |
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| Formulation B and cyclosporine ophthalmic emulsion 0.05% | Other | PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% |
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| Formulation A and Formulation B | Experimental | PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine ophthalmic emulsion Formulation A | Drug | One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) | Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP) | Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe). |
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Inclusion Criteria:
Parallel-Group Phase:
Paired-Eye Phase:
Exclusion Criteria:
Parallel-Group Phase:
Parallel-Group and Paired-Eye Phases:
Paired-Eye Phase:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States |
This study included a parallel-group phase (PGP) and a paired-eye phase (PEP). The paired-eye phase of the study began after the parallel-group phase completed. The parallel-group phase enrolled healthy volunteers and the paired-eye phase enrolled patients with dry eye symptoms.
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| ID | Title | Description |
|---|---|---|
| FG000 | PGP: Cyclosporine Formulation A | Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A |
| FG001 | PGP: Cyclosporine Formulation B | PGP: cyclosporine ophthalmic emulsion Formulation B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| cyclosporine ophthalmic emulsion Formulation B | Drug | One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3. |
|
| cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% | Drug | One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day. |
|
|
| cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% | Drug | One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day. |
|
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| cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B | Drug | One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day. |
|
| 3 Days |
| Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1 | Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe). | Day 1 |
| FG002 | PEP: Cyclosporine Formulation A and Cyclosporine 0.05% | Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% |
| FG003 | PEP: Cyclosporine Formulation B and Cyclosporine 0.05% | PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% |
| FG004 | PEP: Cyclosporine Formulation A and Cyclosporine Formulation B | PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PGP: Cyclosporine Formulation A | Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A |
| BG001 | PGP: Cyclosporine Formulation B | PGP: cyclosporine ophthalmic emulsion Formulation B |
| BG002 | PEP: Cyclosporine Formulation A and Cyclosporine 0.05% | Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% |
| BG003 | PEP: Cyclosporine Formulation B and Cyclosporine 0.05% | PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% |
| BG004 | PEP: Cyclosporine Formulation A and Cyclosporine Formulation B | PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B |
| 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) | Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured. | Safety Population: All randomized subjects who were treated with at least 1 dose of study medication. | Posted | Number | Nanogram/milliliter (ng/mL) | Day 1 |
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| Secondary | Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP) | Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe). | Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol. | Posted | Number | Number of Subjects | 3 Days |
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| Secondary | Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1 | Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe). | Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol. | Posted | Number | Number of Eyes | Day 1 | Eyes | Participants |
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SAEs and AEs are reported by treatment assignment or arm as randomized not by individual intervention received.
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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 | PGP: Cyclosporine Formulation A | Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A | 0 | 10 | 4 | 10 | ||
| EG001 | PGP: Cyclosporine Formulation B | PGP: cyclosporine ophthalmic emulsion Formulation B | 0 | 10 | 2 | 10 | ||
| EG002 | PEP: Cyclosporine Formulation A and Cyclosporine 0.05% | Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% | 0 | 8 | 5 | 8 | ||
| EG003 | PEP: Cyclosporine Formulation B and Cyclosporine 0.05% | PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% | 0 | 8 | 8 | 8 | ||
| EG004 | PEP: Cyclosporine Formulation A and Cyclosporine Formulation B | PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B | 0 | 8 | 8 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA (13.1) | Systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA (13.1) | Systematic Assessment |
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| Abnormal Sensation in Eye | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Eyelid Irritation | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dysguesia | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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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, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| > 30 to 40 years |
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| > 40 years |
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| Male |
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| Time = 1 hour |
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| Time = 3 hours |
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| Eyes |
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