Long Term Administration Study of OPC-12759 Ophthalmic Suspension

Otsuka

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: OPC-12759 Ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818324

037E-08-002

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Enrollment: 154 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Out patient;
2. Ocular discomfort severity is moderate to severe;
3. Corneal-conjunctival damage is moderate to severe;
4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
5. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion criteria

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
2. Ocular hypertention patient or glaucoma patient with ophthalmic solution;
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
4. Anticipated use of contact lens during the study;
5. Patient with punctal plug;
6. Any history of ocular surgery within 12 months;
7. Female patients who are pregnant, possibly pregnant or breast feeding;
8. Known hypersensitivity to any component of the study drug or procedual medications;
9. Receipt of any investigational product within 4 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

154 participants in 1 patient group

OPC-12759 Ophthalmic suspension

Experimental group

Description:

Instillation, 4times/day

Treatment:

Drug: OPC-12759 Ophthalmic suspension