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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
History of Changes
  Purpose

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


Condition Intervention Phase
Dry Eye Syndromes
 Drug: placebo
Drug: 1% OPC-12759 ophthalmic suspension
Drug: 2% OPC-12759 ophthalmic suspension
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 308
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
 Drug: placebo
comparison of different dosages of drug
Experimental: 1% OPC-12759 ophthalmic suspension
1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
 Drug: 1% OPC-12759 ophthalmic suspension
comparison of different dosages of drug
Experimental: 2% OPC-12759 ophthalmic suspension
2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
 Drug: 2% OPC-12759 ophthalmic suspension
comparison of different dosages of drug

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475319

Locations
Japan
Chubu region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Satoshi Oshima Division of dermatologicals and ophthalmologicals
  More Information

No publications provided by Otsuka Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00475319     History of Changes
Other Study ID Numbers: 037E-06-001
Study First Received: May 16, 2007
Results First Received: January 31, 2013
Last Updated: June 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Dry Eye Syndromes
OPC-12759

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Rebamipide
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013