Confirmatory Study of OPC-12759 Ophthalmic Solution

Otsuka

Status and phase: Completed; Phase 3

Conditions: Dry Eye

Treatments: Drug: Placebo; Drug: OPC-12759

Study type: Interventional

Funder types: Industry

Identifiers

NCT01660256

037E-11-003

JapicCTI-121920 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

Enrollment: 209 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 dry eye
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: Single Blind

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209 participants in 3 patient groups, including a placebo group

OPC-12759 ophthalmic solution

Experimental group

Description:

OPC-12759 ophthalmic solution

Treatment:

Drug: OPC-12759

Placebo

Placebo Comparator group

Description:

OPC-12759 ophthalmic solution 0%

Treatment:

Drug: Placebo

OPC-12759 ophthalmic suspension

Active Comparator group

Description:

OPC-12759 ophthalmic suspension

Treatment:

Drug: OPC-12759