Confirmatory Study of OPC-12759 Ophthalmic Suspension
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ClinicalTrials.gov Identifier: NCT00885079 |
Recruitment Status :
Completed
First Posted : April 21, 2009
Results First Posted : December 12, 2013
Last Update Posted : December 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndromes | Drug: OPC-12759 Ophthalmic suspension Drug: Hyalein Mini Ophthalmic solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 188 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | April 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Rebamipide
Instillation,4 times/day for 4 weeks
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Drug: OPC-12759 Ophthalmic suspension
OPC-12759 Ophthalmic suspension 2% |
Active Comparator: Hyaluronate
Instillation,6 times/day for 4 weeks
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Drug: Hyalein Mini Ophthalmic solution
Hyalein Mini Ophthalmic solution 0.1% |
- Change in Fluorescein Corneal Staining (FCS) Score From Baseline [ Time Frame: Baseline, Weeks4 ]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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
- Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline [ Time Frame: Baseline, Weeks4 ]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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 keratoconjunctivitis sicca
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885079
Japan | |
Kyushu region | |
Kagoshima, Japan | |
Chushikoku region | |
Matsuyama, Japan | |
Tokai region | |
Nagoya, Japan | |
Kansai region | |
Osaka, Japan | |
Kanto region | |
Tokyo, Japan |
Study Chair: | Eiji Murakami | OPCJ-DDO |
Responsible Party: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00885079 |
Other Study ID Numbers: |
037E-08-001 |
First Posted: | April 21, 2009 Key Record Dates |
Results First Posted: | December 12, 2013 |
Last Update Posted: | December 12, 2013 |
Last Verified: | November 2013 |
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Rebamipide |
Ophthalmic Solutions Pharmaceutical Solutions Anti-Ulcer Agents Gastrointestinal Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Enzyme Inhibitors |