Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: placebo; Drug: 1% OPC-12759 ophthalmic suspension; Drug: 2% OPC-12759 ophthalmic suspension

• Registration Number: NCT00475319
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-21
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Results First Submitted: 2013-01-31
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-01
• Last Update Submitted: 2013-06-04
• Results First Posted: 2013-06-05
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
1% OPC-12759 ophthalmic suspension	1% OPC-12759 ophthalmic suspension	1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
2% OPC-12759 ophthalmic suspension	2% OPC-12759 ophthalmic suspension	2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)	Baseline, 4weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)	Baseline, 4weeks	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.