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This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESTASIS® | Active Comparator | Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) |
|
| REFRESH ENDURA® | Active Comparator | Artificial Tears (REFRESH ENDURA®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) | Drug | Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Clinical Success at Month 6 | Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RESTASIS® | Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) |
| FG001 | REFRESH ENDURA® | Artificial Tears (REFRESH ENDURA®) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
| |||||||||||||
| Post Treatment Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RESTASIS® | Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) |
| BG001 | REFRESH ENDURA® | Artificial Tears (REFRESH ENDURA®) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Patients With Clinical Success at Month 6 | Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase. | Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of < 25 mm in the 3 central regions of the eye on Day 2. | Posted | Number | Percentage of Patients | Month 6 |
|
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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 | RESTASIS® | Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seasonal allergy | Immune system disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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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 |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Artificial Tears REFRESH ENDURA® | Drug | REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery |
|
| Baseline, Month 6 |
| Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement). | Baseline, Month 6 |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Artificial Tears (REFRESH ENDURA®) |
|
|
| Secondary | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening). | Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Cells per cubic millimeter (cells/mm^3) | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement). | Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized). | Posted | Median | Full Range | Cells per square millimeter (cells/mm^2) | Baseline, Month 6 |
|
|
|
| 1 |
| 68 |
| 16 |
| 68 |
| EG001 | REFRESH ENDURA® | Artificial Tears (REFRESH ENDURA®) | 1 | 69 | 8 | 69 |
| Infected bites | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | 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
| D000602 |
| Amino Acids, Peptides, and Proteins |
| Worse Eye: Baseline |
|
| Worse Eye: Change from Baseline at Month 6 |
|
| Worse Eye: Baseline |
|
| Worse Eye: Change from Baseline at Month 6 |
|