Confirmatory Study of OPC-12759 Ophthalmic Solution

Dry Eye Clinical Trial

Official title:

Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660256
• Other study ID #: 037E-11-003
• Secondary ID: JapicCTI-121920
• Status: Completed
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: April 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• 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 dry eye

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• OPC-12759
Instillation, 4 times/day for 4 weeks
• Placebo

Locations

Country	Name	City	State
Japan	Kansai Region	Kansai Region
Japan	Kanto region	Kanto Region
Japan	Kyushu region	Kyushu Region
Japan	Tokai region	Tokai Region

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.; Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test.	Baseline, Week 4
Secondary	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 score from 0 to 3, and the total score was calculated (0-18). 0 is better.; The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution.	Baseline, Week 4