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Completed

NCT Number: NCT00475319

Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to evaluate the dose-response of OPC-12759 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

Chubu Region, Japan

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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
  • 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

Placebo

Drug

comparison of different dosages of drug

1% OPC-12759 ophthalmic suspension

Drug

comparison of different dosages of drug

2% OPC-12759 ophthalmic suspension

Drug

comparison of different dosages of drug

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 21, 2007
Registry last updated
Jun 13, 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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