Long Term Administration Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00818324
First received: January 4, 2009
Last updated: January 7, 2014
Last verified: January 2014

January 4, 2009
January 7, 2014
January 2009
September 2010   (final data collection date for primary outcome measure)
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ] [ 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. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Fluorescein corneal staining score [ Time Frame: Weeks2,4,8,12,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00818324 on ClinicalTrials.gov Archive Site
Not Provided
Lisamingreen conjunctive staining score [ Time Frame: Weeks2,4,8,12,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ] [ Designated as safety issue: No ]
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. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Not Provided
 
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dry Eye Syndromes
Drug: OPC-12759 Ophthalmic suspension
Instillation,4times/day,for 52weeks
Experimental: OPC-12759 Ophthalmic suspension
Instillation, 4times/day
Intervention: Drug: OPC-12759 Ophthalmic suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
January 2011
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Out patient;
  2. Ocular discomfort severity is moderate to severe;
  3. Corneal-conjunctival damage is moderate to severe;
  4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
  5. 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 scicca;
  2. Ocular hypertention 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 procedual 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
 
NCT00818324
037E-08-002
No
Eiji Murakami/Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Study Chair: Eiji Murakami OPCJ-DDO
Otsuka Pharmaceutical Co., Ltd.
January 2014

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