Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
NCT ID: NCT01319773
Last Updated: 2015-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2010-11-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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cyclosporine ophthalmic emulsion Formulation A (Formulation A)
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
cyclosporine ophthalmic emulsion Formulation A
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.
cyclosporine ophthalmic emulsion Formulation B (Formulation B)
PGP: cyclosporine ophthalmic emulsion Formulation B
cyclosporine ophthalmic emulsion Formulation B
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.
Formulation A and cyclosporine ophthalmic emulsion 0.05%
Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
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.
Formulation B and cyclosporine ophthalmic emulsion 0.05%
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
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.
Formulation A and Formulation B
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
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.
Interventions
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cyclosporine ophthalmic emulsion Formulation A
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.
cyclosporine ophthalmic emulsion Formulation B
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%
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%
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.
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weigh at least 110 lbs
* 18 to 45 years old
Paired-Eye Phase:
* Dry eye disease in both eyes
Exclusion Criteria
* Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
* Has donated blood within 90 days
* Significant weight change (over 10 lbs) within 60 days
* Previous use of RESTASIS®
Parallel-Group and Paired-Eye Phases:
* Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
* Consumption of alcohol products within 72 hours
Paired-Eye Phase:
* Previous ocular surgery
* Use of RESTASIS® within 30 days
18 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Newport Beach, California, United States
Countries
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Other Identifiers
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192371-021
Identifier Type: -
Identifier Source: org_study_id
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