Long Term Administration Study of OPC-12759 Ophthalmic Suspension

Dry Eye Syndromes Clinical Trial

Official title:

Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818324
• Other study ID #: 037E-08-002
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2009
• Last updated: January 7, 2014
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2014
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Out patient;

2. Ocular discomfort severity is moderate to severe;

3. Corneal-conjunctival damage is moderate to severe;

4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;

5. 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 scicca;

2. Ocular hypertention 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 procedual medications;

9. Receipt of any investigational product within 4 months.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• OPC-12759 Ophthalmic suspension
Instillation,4times/day,for 52weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score	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. Baseline scores and those obtained at each examination time point were compared (paired t-test).	Baseline, Week2, Week4, Week28, Week52	No
Primary	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	No