Confirmatory Study of OPC-12759 Ophthalmic Solution

NCT01660256 | Completed Phase 3 Results

• 2 other identifiers: 037E-11-003JapicCTI-121920
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change in Fluorescein Corneal Staining (FCS) Score From Baseline

  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.

  Baseline, Week 4

Secondary Outcomes (1)

• Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline

  Baseline, Week 4

Study Arms (3)

OPC-12759 ophthalmic solution

EXPERIMENTAL

OPC-12759 ophthalmic solution

Drug: OPC-12759

Placebo

PLACEBO COMPARATOR

OPC-12759 ophthalmic solution 0%

Drug: Placebo

OPC-12759 ophthalmic suspension

ACTIVE COMPARATOR

OPC-12759 ophthalmic suspension

Drug: OPC-12759

Interventions

OPC-12759 DRUG

Instillation, 4 times/day for 4 weeks

Also known as: rebamipide

OPC-12759 ophthalmic solution; OPC-12759 ophthalmic suspension

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out patient
• Subjective complaint of dry eye that has been present for minimum 20 months
• Ocular discomfort severity is moderate to severe
• Corneal - conjunctival damage is moderate to severe
• Unanesthetized Schirmer's test score of 5mm/5minutes or less
• Best corrected visual acuity of 0.2 or better in both eyes

You may not qualify if:

• Presence of anterior segment disease or disorder other than that associated with dry eye
• Ocular hypertension patient or glaucoma patient with ophthalmic solution
• Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
• Anticipated use of contact lens during the study
• Patient with punctal plug
• Any history of ocular surgery within 12 months
• Female patients who are pregnant,possibly pregnant or breast feeding
• Known hypersensitivity to any component of the study drug or procedural medications
• Receipt of any investigational product within 4 months.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Kansai Region

Kansai Region, Japan

Location

Kanto region

Kanto Region, Japan

Location

Kyushu region

Kyushu Region, Japan

Location

Tokai region

Tokai Region, Japan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Eiji Murakami

  Director of Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 5, 2021
• Results First Posted: May 5, 2021

Record last verified: 2021-04

Locations

JP (4)