Trial Outcomes & Findings for Late Phase 2 Study of OPC-12759 Ophthalmic Suspension (NCT NCT00475319)
NCT ID: NCT00475319
Last Updated: 2013-06-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
308 participants
Primary outcome timeframe
Baseline, 4weeks
Results posted on
2013-06-13
Participant Flow
Subjects were recruited in Japan between 2007 and 2008
Participant flow results are based on the safety set.
Participant milestones
| Measure |
1% OPC-12759 Groups
1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
2% OPC-12759 Groups
2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
Placebo
0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
103
|
102
|
103
|
|
Overall Study
COMPLETED
|
101
|
101
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
Baseline characteristics by cohort
| Measure |
1% OPC-12759 Groups
n=103 Participants
1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
2% OPC-12759 Groups
n=102 Participants
2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
Placebo
n=103 Participants
0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
193 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
|
Age Continuous
|
53.7 years
STANDARD_DEVIATION 16.6 • n=99 Participants
|
56.3 years
STANDARD_DEVIATION 16.9 • n=107 Participants
|
55.6 years
STANDARD_DEVIATION 17.2 • n=206 Participants
|
55.2 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
269 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
103 participants
n=99 Participants
|
102 participants
n=107 Participants
|
103 participants
n=206 Participants
|
308 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4weeksFCS 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.
Outcome measures
| Measure |
1% OPC-12759 Ophthalmic Suspension
n=103 Participants
1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
|
2% OPC-12759 Ophthalmic Suspension
n=102 Participants
2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
|
Placebo
n=103 Participants
0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
|
|---|---|---|---|
|
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
|
-3.5 FCS score
Standard Deviation 2.2
|
-3.7 FCS score
Standard Deviation 2.4
|
-1.8 FCS score
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, 4weeksLGCS 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.
Outcome measures
| Measure |
1% OPC-12759 Ophthalmic Suspension
n=103 Participants
1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
|
2% OPC-12759 Ophthalmic Suspension
n=102 Participants
2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
|
Placebo
n=103 Participants
0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
|
|---|---|---|---|
|
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)
|
-4.0 LGCS score
Standard Deviation 2.8
|
-4.5 LGCS score
Standard Deviation 2.9
|
-1.9 LGCS score
Standard Deviation 3.0
|
Adverse Events
1% OPC-12759 Groups
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
2% OPC-12759 Groups
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1% OPC-12759 Groups
n=103 participants at risk
1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
2% OPC-12759 Groups
n=102 participants at risk
2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
Placebo
n=103 participants at risk
0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
Other adverse events
| Measure |
1% OPC-12759 Groups
n=103 participants at risk
1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
2% OPC-12759 Groups
n=102 participants at risk
2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
Placebo
n=103 participants at risk
0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
|
|---|---|---|---|
|
Eye disorders
Abnormal sensation in eye
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Eye disorders
Blepharitis
|
1.9%
2/103 • Number of events 2
|
0.98%
1/102 • Number of events 1
|
1.9%
2/103 • Number of events 2
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Eye disorders
Conjunctivitis allergic
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Eye disorders
Corneal erosion
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.97%
1/103 • Number of events 1
|
|
Eye disorders
Episcleritis
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Eye disorders
Eye irritation
|
3.9%
4/103 • Number of events 4
|
2.0%
2/102 • Number of events 2
|
4.9%
5/103 • Number of events 5
|
|
Eye disorders
Iritis
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.97%
1/103 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Eye disorders
Foreign body sensation in eyes
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/103
|
2.0%
2/102 • Number of events 2
|
0.00%
0/103
|
|
Eye disorders
Eyelids pruritus
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Eye disorders
Eye pruritus
|
0.97%
1/103 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Gastrointestinal disorders
Dental caries
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Gastrointestinal disorders
Nausea
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
General disorders
Oedema peripheral
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
General disorders
Pain
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
Cystitis
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
4/103 • Number of events 4
|
2.9%
3/102 • Number of events 3
|
1.9%
2/103 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
1.9%
2/103 • Number of events 2
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.97%
1/103 • Number of events 1
|
0.00%
0/102
|
0.00%
0/103
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/103
|
0.00%
0/102
|
1.9%
2/103 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/103
|
0.00%
0/102
|
1.9%
2/103 • Number of events 2
|
|
Investigations
Blood potassium increased
|
1.9%
2/103 • Number of events 2
|
0.00%
0/102
|
0.00%
0/103
|
|
Investigations
Blood urea increased
|
0.97%
1/103 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Investigations
Glucose urine present
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Investigations
Platelet count decreased
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Investigations
White blood cell count decreased
|
0.00%
0/103
|
2.0%
2/102 • Number of events 2
|
1.9%
2/103 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.97%
1/103 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Nervous system disorders
Dysgeusia
|
13.6%
14/103 • Number of events 14
|
15.7%
16/102 • Number of events 16
|
0.97%
1/103 • Number of events 1
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/103
|
0.98%
1/102 • Number of events 1
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/103
|
0.00%
0/102
|
0.97%
1/103 • Number of events 1
|
Additional Information
Eiji Murakami
Dermatologicals & Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
Phone: +81-6-6231-6067
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place