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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319773
• Other study ID #: 192371-021
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2011
• Last updated: August 25, 2015
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: August 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1	No
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).	3 Days	No
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).	Day 1	No