Dose-response Study of OPC-12759 Ophthalmic Suspension

Dry Eye Syndromes Clinical Trial

Official title:

Dose-response Study of OPC-12759 Ophthalmic Suspension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234078
• Other study ID #: 037E-04-002
• Secondary ID: JapicCTI-050040
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2005
• Last updated: January 20, 2014
• Start date: January 2005
• Est. completion date: March 2007

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 Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2007
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Outpatient.

2. Subjective complaint of dry eye that has been present for minimum 20 months.

3. Primary ocular discomfort severity is moderate to severe.

4. Corneal - conjunctival damage is moderate to severe.

5. Unanesthetized Schirmer's test score of 7mm/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. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.

3. Anticipated use of contact lens during the study.

4. Any history of ocular surgery within 12 months.

5. Female patients who are pregnant, possibly pregnant or breast feeding;

6. Known hypersensitivity to any component of the study drug or procedural medications.

7. Receipt of any investigational product within 4 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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:
• 0.5% OPC-12759

• 1% OPC-12759

• 2% OPC-12759

• placebo

Locations

Country	Name	City	State
Japan	Otsuka Pharmaceutical Co., Ltd.	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 to Last Observation Carried Forward (LOCF)	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. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.	baseline, 12 weeks	No
Primary	Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)	POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.	Baseline, 12 weeks	No