Dry Eye Syndromes
Conditions
Keywords
Dry Eye Syndromes, OPC-12759
Brief summary
The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients
Interventions
DRUGplacebo
comparison of different dosages of drug
DRUG1% OPC-12759 ophthalmic suspension
comparison of different dosages of drug
DRUG2% OPC-12759 ophthalmic suspension
comparison of different dosages of drug
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) | Baseline, 4weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | Baseline, 4weeks | 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. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited in Japan between 2007 and 2008
Pre-assignment details
Participant flow results are based on the safety set.
Participants by arm
| Arm | Count |
|---|---|
| 1% OPC-12759 Groups 1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks | 103 |
| 2% OPC-12759 Groups 2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks | 102 |
| Placebo 0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks | 103 |
| Total | 308 |
Baseline characteristics
| Characteristic | 2% OPC-12759 Groups | Placebo | 1% OPC-12759 Groups | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 41 Participants | 41 Participants | 33 Participants | 115 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 62 Participants | 70 Participants | 193 Participants |
| Age Continuous | 56.3 years STANDARD_DEVIATION 16.9 | 55.6 years STANDARD_DEVIATION 17.2 | 53.7 years STANDARD_DEVIATION 16.6 | 55.2 years STANDARD_DEVIATION 16.9 |
| Region of Enrollment Japan | 102 participants | 103 participants | 103 participants | 308 participants |
| Sex: Female, Male Female | 86 Participants | 90 Participants | 93 Participants | 269 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 10 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 103 | 31 / 102 | 27 / 103 |
| serious Total, serious adverse events | 0 / 103 | 0 / 102 | 1 / 103 |
Outcome results
Primary
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
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.
Time frame: Baseline, 4weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% OPC-12759 Ophthalmic Suspension | Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) | -3.5 FCS score | Standard Deviation 2.2 |
| 2% OPC-12759 Ophthalmic Suspension | Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) | -3.7 FCS score | Standard Deviation 2.4 |
| Placebo | Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF) | -1.8 FCS score | Standard Deviation 2 |
p-value: 0.001t-test, 2 sided
Secondary
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)
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.
Time frame: Baseline, 4weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% OPC-12759 Ophthalmic Suspension | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | -4.0 LGCS score | Standard Deviation 2.8 |
| 2% OPC-12759 Ophthalmic Suspension | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | -4.5 LGCS score | Standard Deviation 2.9 |
| Placebo | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | -1.9 LGCS score | Standard Deviation 3 |
p-value: 0.001t-test, 2 sided