Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00475319
First received: May 16, 2007
Last updated: June 4, 2013
Last verified: May 2013

May 16, 2007
June 4, 2013
May 2007
March 2008   (final data collection date for primary outcome measure)
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, 4weeks ] [ Designated as safety issue: No ]
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.
fluorescein corneal staining total score at week 4 [ Time Frame: 4weeks after treatment ]
Complete list of historical versions of study NCT00475319 on ClinicalTrials.gov Archive Site
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, 4weeks ] [ Designated as safety issue: No ]
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.
Lisamingreen conjunctive staining score at week 4 [ Time Frame: 4weeks after treatment ]
Not Provided
Not Provided
 
Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Dry Eye Syndromes
  • Drug: placebo
    comparison of different dosages of drug
  • Drug: 1% OPC-12759 ophthalmic suspension
    comparison of different dosages of drug
  • Drug: 2% OPC-12759 ophthalmic suspension
    comparison of different dosages of drug
  • Placebo Comparator: Placebo
    0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
    Intervention: Drug: placebo
  • Experimental: 1% OPC-12759 ophthalmic suspension
    1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
    Intervention: Drug: 1% OPC-12759 ophthalmic suspension
  • Experimental: 2% OPC-12759 ophthalmic suspension
    2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
    Intervention: Drug: 2% OPC-12759 ophthalmic suspension
Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
June 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Outpatient
  2. Subjective complaint of dry eye that has been present for minimum 20 months
  3. Ocular discomfort severity is moderate to severe
  4. Corneal - conjunctival damage is moderate to severe
  5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
  6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

  1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
  2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
  3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
  4. Anticipated use of contact lens during the study
  5. Patient with punctal plug
  6. Any history of ocular surgery within 12 months
  7. Female patients who are pregnant, possibly pregnant or breast feeding
  8. Known hypersensitivity to any component of the study drug or procedural medications
  9. Receipt of any investigational product within 4 months
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00475319
037E-06-001
No
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Study Director: Satoshi Oshima Division of dermatologicals and ophthalmologicals
Otsuka Pharmaceutical Co., Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP