Trial Outcomes & Findings for Confirmatory Study of OPC-12759 Ophthalmic Suspension (NCT NCT00885079)
NCT ID: NCT00885079
Last Updated: 2013-12-12
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. 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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
Baseline, Weeks4
Results posted on
2013-12-12
Participant Flow
Participant milestones
| Measure |
Rebamipide
Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
|
Hyaluronate
Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
95
|
|
Overall Study
COMPLETED
|
91
|
91
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Confirmatory Study of OPC-12759 Ophthalmic Suspension
Baseline characteristics by cohort
| Measure |
Rebamipide
n=93 Participants
Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
|
Hyaluronate
n=95 Participants
Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Age Continuous
|
58.0 years
STANDARD_DEVIATION 17.7 • n=93 Participants
|
55.2 years
STANDARD_DEVIATION 16.9 • n=4 Participants
|
56.6 years
STANDARD_DEVIATION 17.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
163 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
93 participants
n=93 Participants
|
95 participants
n=4 Participants
|
188 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks4FCS 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
Outcome measures
| Measure |
Rebamipide
n=93 Participants
Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
|
Hyaluronate
n=95 Participants
Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
|
|---|---|---|
|
Change in Fluorescein Corneal Staining (FCS) Score From Baseline
|
-3.7 units on a scale
Standard Deviation 0.3
|
-2.9 units on a scale
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: Baseline, Weeks4LGCS 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.
Outcome measures
| Measure |
Rebamipide
n=93 Participants
Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
|
Hyaluronate
n=95 Participants
Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
|
|---|---|---|
|
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
|
-4.5 units on a scale
Standard Deviation 3.2
|
-2.4 units on a scale
Standard Deviation 2.5
|
Adverse Events
Rebamipide
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Hyaluronate
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rebamipide
n=93 participants at risk
Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
|
Hyaluronate
n=95 participants at risk
Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
|
|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Chalazion
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
1.1%
1/93 • Number of events 1
|
2.1%
2/95 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Eye discharge
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Eye irritation
|
0.00%
0/93
|
2.1%
2/95 • Number of events 2
|
|
Eye disorders
Eye pain
|
0.00%
0/93
|
3.2%
3/95 • Number of events 3
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Vision blurred
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Eye disorders
Visual impairment
|
2.2%
2/93 • Number of events 2
|
0.00%
0/95
|
|
Eye disorders
Conjunctival hyperaemia
|
1.1%
1/93 • Number of events 1
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
4.3%
4/93 • Number of events 4
|
2.1%
2/95 • Number of events 2
|
|
Eye disorders
Ocular discomfort
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
General disorders
Chest discomfort
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Thirst
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/93 • Number of events 1
|
2.1%
2/95 • Number of events 2
|
|
Infections and infestations
Onychomycosis
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Infections and infestations
Sinusitis
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/93 • Number of events 1
|
1.1%
1/95 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Investigations
Blood urine present
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Investigations
White blood cell count decreased
|
3.2%
3/93 • Number of events 3
|
0.00%
0/95
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/93 • Number of events 1
|
0.00%
0/95
|
|
Nervous system disorders
Dizziness
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Dysgeusia (bitter taste)
|
9.7%
9/93 • Number of events 9
|
0.00%
0/95
|
|
Nervous system disorders
Headache
|
2.2%
2/93 • Number of events 2
|
0.00%
0/95
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/93
|
1.1%
1/95 • Number of events 1
|
Additional Information
Mr. Kyoji Imaoka
Otsuka Pharmaceutical Co., Ltd.
Phone: -81-6-6943-7722
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place