Dose-response Study of OPC-12759 Ophthalmic Suspension

Otsuka

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: placebo; Drug: 0.5% OPC-12759; Drug: 1% OPC-12759; Drug: 2% OPC-12759

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234078

JapicCTI-050040

037E-04-002

Details and patient eligibility

About

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

Enrollment: 290 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. Primary ocular discomfort severity is moderate to severe.
4. Corneal - conjunctival damage is moderate to severe.
5. Unanesthetized Schirmer's test score of 7mm/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. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
3. Anticipated use of contact lens during the study.
4. Any history of ocular surgery within 12 months.
5. Female patients who are pregnant, possibly pregnant or breast feeding;
6. Known hypersensitivity to any component of the study drug or procedural medications.
7. Receipt of any investigational product within 4 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 4 patient groups, including a placebo group

0.5% OPC-12759

Experimental group

Description:

0.5% OPC-12759 (rebamipide) ophthalmic suspension

Treatment:

Drug: 0.5% OPC-12759

1% OPC-12759

Experimental group

Description:

1% OPC-12759 (rebamipide) ophthalmic suspension

Treatment:

Drug: 1% OPC-12759

2% OPC-12759

Experimental group

Description:

2% OPC-12759 (rebamipide) ophthalmic suspension

Treatment:

Drug: 2% OPC-12759

placebo

Placebo Comparator group

Description:

placebo of OPC-12759 (rebamipide) ophthalmic suspension

Treatment:

Drug: placebo