Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Otsuka

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: 2% OPC-12759 ophthalmic suspension; Drug: placebo; Drug: 1% OPC-12759 ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475319

037E-06-001

Details and patient eligibility

About

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

Enrollment: 308 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Outpatient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. 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 sicca
2. Ocular hypertension 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 procedural medications
9. Receipt of any investigational product within 4 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

308 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Treatment:

Drug: placebo

1% OPC-12759 ophthalmic suspension

Experimental group

Description:

1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Treatment:

Drug: 1% OPC-12759 ophthalmic suspension

2% OPC-12759 ophthalmic suspension

Experimental group

Description:

2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Treatment:

Drug: 2% OPC-12759 ophthalmic suspension