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Completed

NCT Number: NCT01660256

Confirmatory Study of OPC-12759 Ophthalmic Solution

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.

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Key information

Conditions

Dry Eye 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
  • 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 dry eye
  • 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

Drug

Instillation, 4 times/day for 4 weeks

Other names: rebamipide

Placebo

Drug

Primary outcomes

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

    Time frame: Baseline, Week 4

    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.

Secondary outcomes

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

    Time frame: Baseline, Week 4

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2012
Registry last updated
May 5, 2021

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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