Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Dry Eye Syndromes Clinical Trial

Official title:

Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475319
• Other study ID #: 037E-06-001
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2007
• Last updated: June 4, 2013
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2013
• 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 suspension in dry eye patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• 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. 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• placebo
comparison of different dosages of drug
• 1% OPC-12759 ophthalmic suspension
comparison of different dosages of drug
• 2% OPC-12759 ophthalmic suspension
comparison of different dosages of drug

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
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, 4weeks	No
Secondary	Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)	LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared.	Baseline, 4weeks	No