Confirmatory Study of OPC-12759 Ophthal… | Clinical Trial

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyushu region, Kagoshima, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Out patient
Subjective complaint of dry eye that has been present for minimum 20 months
Ocular discomfort severity is moderate to severe
Corneal - conjunctival damage is moderate to severe
Unanesthetized Schirmer's test score of 5mm/5minutes or less
Best corrected visual acuity of 0.2 or better in both eyes

Exclusion criteria

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
Ocular hypertension patient or glaucoma patient with ophthalmic solution
Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
Anticipated use of contact lens during the study
Patient with punctal plug
Any history of ocular surgery within 12 months
Female patients who are pregnant,possibly pregnant or breast feeding
Known hypersensitivity to any component of the study drug or procedural medications
Receipt of any investigational product within 4 months.

Treatment and study plan

OPC-12759 Ophthalmic suspension

Drug

OPC-12759 Ophthalmic suspension 2%

Hyalein Mini Ophthalmic solution

Drug

Hyalein Mini Ophthalmic solution 0.1%

Primary outcomes

Change in Fluorescein Corneal Staining (FCS) Score From Baseline

Time frame: Baseline, Weeks4

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
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline

Time frame: Baseline, Weeks4

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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Apr 21, 2009
Registry last updated: Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed