Confirmatory Study of OPC-12759 Ophthalmic Solution

Phase 3

Completed

• Conditions: Dry Eye
• Interventions: Drug: OPC-12759; Drug: Placebo

• Registration Number: NCT01660256
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Results First Submitted: 2021-03-17
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Results First Posted: 2021-05-05
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPC-12759 ophthalmic solution	OPC-12759	OPC-12759 ophthalmic solution
Placebo	Placebo	OPC-12759 ophthalmic solution 0%
OPC-12759 ophthalmic suspension	OPC-12759	OPC-12759 ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Change in Fluorescein Corneal Staining (FCS) Score From Baseline	Baseline, Week 4	FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.; Changes of the FCS score from baseline to the last dose (last observation carried forward \[LOCF\]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test.

Secondary Outcome Measures

Name	Time	Method
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline	Baseline, Week 4	LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better.; The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution.

Trial Locations

Locations (4)

Kansai Region; 🇯🇵 Kansai Region, Japan

Kanto region; 🇯🇵 Kanto Region, Japan

Kyushu region; 🇯🇵 Kyushu Region, Japan

Tokai region; 🇯🇵 Tokai Region, Japan