Confirmatory Study of OPC-12759 Ophthalmic Suspension

Otsuka

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: OPC-12759 Ophthalmic suspension; Drug: Hyalein Mini Ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885079

037E-08-001

Details and patient eligibility

About

The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Enrollment: 188 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Out patient
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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 2 patient groups

Rebamipide

Experimental group

Description:

Instillation,4 times/day for 4 weeks

Treatment:

Drug: OPC-12759 Ophthalmic suspension

Hyaluronate

Active Comparator group

Description:

Instillation,6 times/day for 4 weeks

Treatment:

Drug: Hyalein Mini Ophthalmic solution