Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

Otsuka

Status and phase: Completed; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost ophthalmic solution; Drug: Carteolol long-acting ophthalmic solution; Drug: OPC-1085EL ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02108288

1085EL-13-004

Details and patient eligibility

About

OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who are considered medically healthy per investigator's judgment

Exclusion criteria

• Subjects with ocular conditions as defined by the protocol
• Subjects with intraocular pressure: <10 or ≥22 mmHg

Trial design

30 participants in 3 patient groups

OPC-1085EL ophthalmic solution

Experimental group

Description:

Once daily

Treatment:

Drug: OPC-1085EL ophthalmic solution

Carteolol long-acting ophthalmic solution

Active Comparator group

Description:

Once daily

Treatment:

Drug: Carteolol long-acting ophthalmic solution

Latanoprost ophthalmic solution

Active Comparator group

Description:

Once daily

Treatment:

Drug: Latanoprost ophthalmic solution