Confirmatory Study of OPC-12759 Ophthalmic Suspension

Dry Eye Syndromes Clinical Trial

Official title:

Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885079
• Other study ID #: 037E-08-001
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2009
• Last updated: November 18, 2013
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2013
• 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 verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 keratoconjunctivitis sicca

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• OPC-12759 Ophthalmic suspension
OPC-12759 Ophthalmic suspension 2%
• Hyalein Mini Ophthalmic solution
Hyalein Mini Ophthalmic solution 0.1%

Locations

Country	Name	City	State
Japan	Kyushu region	Kagoshima
Japan	Chushikoku region	Matsuyama
Japan	Tokai region	Nagoya
Japan	Kansai region	Osaka
Japan	Kanto region	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups	Baseline, Weeks4	No
Primary	Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline	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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.	Baseline, Weeks4	No