Long Term Administration Study of OPC-12759 Ophthalmic Suspension

NCT00818324 | Completed Phase 3 Results

• 1 other identifier: 037E-08-002
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

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

  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. Baseline scores and those obtained at each examination time point were compared (paired t-test).

  Baseline, Week2, Week4, Week28, Week52

Other Outcomes (1)

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

  Baseline, Week2, Week4, Week28, Week52

Study Arms (1)

OPC-12759 Ophthalmic suspension

EXPERIMENTAL

Instillation, 4times/day

Drug: OPC-12759 Ophthalmic suspension

Interventions

OPC-12759 Ophthalmic suspension DRUG

Instillation,4times/day,for 52weeks

OPC-12759 Ophthalmic suspension

Eligibility Criteria

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

You may qualify if:

• Out patient;
• Ocular discomfort severity is moderate to severe;
• Corneal-conjunctival damage is moderate to severe;
• Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds 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 keratoconjunctivitis scicca;
• Ocular hypertention 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 procedual medications;
• Receipt of any investigational product within 4 months.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Unknown Facility

Tokai Region, Japan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Study Officials

• Eiji Murakami

  OPCJ-DDO

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2009
• First Posted: January 7, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 26, 2014
• Results First Posted: February 26, 2014

Record last verified: 2014-01

Locations

JP (5)