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Completed

NCT Number: NCT00234078

Dose-response Study of OPC-12759 Ophthalmic Suspension

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

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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 2

Primary location

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatient.
  • Subjective complaint of dry eye that has been present for minimum 20 months.
  • Primary ocular discomfort severity is moderate to severe.
  • Corneal - conjunctival damage is moderate to severe.
  • Unanesthetized Schirmer's test score of 7mm/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.
  • Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
  • Anticipated use of contact lens during the study.
  • 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

0.5% OPC-12759

Drug

1% OPC-12759

Drug

2% OPC-12759

Drug

Placebo

Drug

Primary outcomes

  1. Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)

    Time frame: baseline, 12 weeks

    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.

  2. Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)

    Time frame: Baseline, 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Oct 6, 2005
Registry last updated
Feb 28, 2014

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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