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

Allergan

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%; Drug: cyclosporine ophthalmic emulsion Formulation B; Drug: cyclosporine ophthalmic emulsion Formulation A; Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%; Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01319773

192371-021

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

44 participants in 5 patient groups

cyclosporine ophthalmic emulsion Formulation A (Formulation A)

Experimental group

Description:

Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A

Treatment:

Drug: cyclosporine ophthalmic emulsion Formulation A

cyclosporine ophthalmic emulsion Formulation B (Formulation B)

Experimental group

Description:

PGP: cyclosporine ophthalmic emulsion Formulation B

Treatment:

Drug: cyclosporine ophthalmic emulsion Formulation B

Formulation A and cyclosporine ophthalmic emulsion 0.05%

Other group

Description:

Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%

Treatment:

Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%

Formulation B and cyclosporine ophthalmic emulsion 0.05%

Other group

Description:

PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%

Treatment:

Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%

Formulation A and Formulation B

Experimental group

Description:

PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B

Treatment:

Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B