Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedResults Posted
Study results publicly available
March 2, 2012
CompletedSeptember 7, 2015
August 1, 2015
2 months
March 18, 2011
January 31, 2012
August 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
3 Days
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Day 1
Study Arms (5)
cyclosporine ophthalmic emulsion Formulation A (Formulation A)
EXPERIMENTALParallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
cyclosporine ophthalmic emulsion Formulation B (Formulation B)
EXPERIMENTALPGP: cyclosporine ophthalmic emulsion Formulation B
Formulation A and cyclosporine ophthalmic emulsion 0.05%
OTHERPaired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
Formulation B and cyclosporine ophthalmic emulsion 0.05%
OTHERPEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
Formulation A and Formulation B
EXPERIMENTALPEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Parallel-Group Phase:
- Weigh at least 110 lbs
- to 45 years old
- Paired-Eye Phase:
- Dry eye disease in both eyes
You may not qualify if:
- Parallel-Group Phase:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Newport Beach, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 22, 2011
Study Start
November 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
September 7, 2015
Results First Posted
March 2, 2012
Record last verified: 2015-08