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Completed

NCT Number: NCT00818324

Long Term Administration Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks 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 3

Primary location

Kansai Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Out patient;
  • Ocular discomfort severity is moderate to severe;
  • Corneal-conjunctival damage is moderate to severe;
  • Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds 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 scicca;
  • Ocular hypertention 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 procedual medications;
  • Receipt of any investigational product within 4 months.

Treatment and study plan

OPC-12759 Ophthalmic suspension

Drug

Instillation,4times/day,for 52weeks

Primary outcomes

  1. Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score

    Time frame: Baseline, Week2, Week4, Week28, Week52

    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. Baseline scores and those obtained at each examination time point were compared (paired t-test).

Other outcomes

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

    Time frame: Baseline, Week2, Week4, Week28, Week52

    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. Baseline scores and those obtained at each examination time point were compared (paired t-test).

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 7, 2009
Registry last updated
Feb 26, 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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