Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
- Conditions
- Dry Eye Syndromes
- Registration Number
- NCT01319773
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Parallel-Group Phase:
- Weigh at least 110 lbs
- 18 to 45 years old
Paired-Eye Phase:
- Dry eye disease in both eyes
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Formulation A and cyclosporine ophthalmic emulsion 0.05% cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% Formulation B and cyclosporine ophthalmic emulsion 0.05% cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% Formulation A and Formulation B cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B cyclosporine ophthalmic emulsion Formulation A (Formulation A) cyclosporine ophthalmic emulsion Formulation A Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A cyclosporine ophthalmic emulsion Formulation B (Formulation B) cyclosporine ophthalmic emulsion Formulation B PGP: cyclosporine ophthalmic emulsion Formulation B
- Primary Outcome Measures
Name Time Method Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) 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
Name Time Method Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP) 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).
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1 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).