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Phase 3 N=209 Randomized Single-blind Treatment

Confirmatory Study of OPC-12759 Ophthalmic Solution

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT01660256 ↗
Enrolled (actual)
209
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Change in Fluorescein Corneal Staining (FCS) Score From Baseline — -3.3; -2.0; -2.9 score on a scale — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
OPC-12759 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Primary completion
Mar 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Fluorescein Corneal Staining (FCS) Score From Baseline		 -3.3; -2.0; -2.9 <0.001 sig
SECONDARY
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline		 -3.2; -1.7; -3.1 <0.001 sig

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01660256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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