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Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

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ClinicalTrials.gov Identifier: NCT01319773
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : March 2, 2012
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: cyclosporine ophthalmic emulsion Formulation A Drug: cyclosporine ophthalmic emulsion Formulation B Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Study Start Date : November 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: cyclosporine ophthalmic emulsion Formulation A (Formulation A)
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
 Drug: 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.
Experimental: cyclosporine ophthalmic emulsion Formulation B (Formulation B)
PGP: cyclosporine ophthalmic emulsion Formulation B
 Drug: 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%
 Drug: 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.
Other Name: RESTASIS®
Formulation B and cyclosporine ophthalmic emulsion 0.05%
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
 Drug: 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.
Other Name: RESTASIS®
Experimental: Formulation A and Formulation B
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP) [ Time Frame: 3 Days ]
    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).

  2. Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1 [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Parallel-Group Phase:

  • Weigh at least 110 lbs
  • 18 to 45 years old

Paired-Eye Phase:

  • Dry eye disease in both eyes

Exclusion Criteria:

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319773


Locations
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United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01319773    
Other Study ID Numbers: 192371-021
First Posted: March 22, 2011    Key Record Dates
Results First Posted: March 2, 2012
Last Update Posted: September 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporine
Cyclosporins
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors