Phase 1 Completed N=30 Randomized

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

Glaucoma · Hypertension

Source: ClinicalTrials.gov NCT02108288 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcomePrimary: Cmax of Carteolol — 0.8558; 0.9984; 1.174; 1.627 ng/mL

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax of Carteolol	0.8558; 0.9984; 1.174; 1.627	—
PRIMARY Cmax of Latanoprost Acid	19.77; 21.22; 18.47; 17.48	—
SECONDARY Tmax of Carteolol	0.25; 0.25; 0.25; 0.38	—
SECONDARY Tmax of Latanoprost Acid	10; 10; 5; 10	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02108288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.