CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 290 enrolled
Drug / intervention
0.5% OPC-12759 +3 moredrug
Likely dose
OPC-12759 ophthalmic suspension 0.5%, 1%, or 2% (doses to be determined in dose-response study)AI-extracted
Key inclusion· 6
  • ✓Outpatient status
  • ✓Subjective complaint of dry eye present for minimum 20 months
  • ✓Primary ocular discomfort severity is moderate to severe
  • ✓Corneal-conjunctival damage is moderate to severe
Key exclusion· 7
  • ✕Anterior segment disease or disorder other than keratoconjunctivitis sicca
  • ✕Anticipated use of any topically-instilled ocular medications or inability to discontinue during study
  • ✕Anticipated use of contact lens during study
  • ✕Any history of ocular surgery within 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00234078
NCT00234078Phase 2Completed
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Dose-response Study of OPC-12759 Ophthalmic Suspension

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 6, 2005·Updated Feb 28, 2014

In Brief

A Phase 2 clinical trial evaluating 0.5% OPC-12759, 1% OPC-12759, and 2 other interventions for Dry Eye Syndromes. Completed, enrolled 290 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartJan 1, 2005
Primary CompletionApr 1, 2006
Study CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.7 years ago

Interventions

0.5% OPC-12759drug

1% OPC-12759drug

2% OPC-12759drug

placebodrug