Trial Outcomes & Findings for Long Term Administration Study of OPC-12759 Ophthalmic Suspension (NCT NCT00818324)
NCT ID: NCT00818324
Last Updated: 2014-02-26
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. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
154 participants
Primary outcome timeframe
Baseline, Week2, Week4, Week28, Week52
Results posted on
2014-02-26
Participant Flow
Participant milestones
| Measure |
2% Rebamipide Group
2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
COMPLETED
|
127
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Baseline characteristics by cohort
| Measure |
2% Rebamipide Group
n=154 Participants
2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
|
|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week2, Week4, Week28, Week52FCS 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).
Outcome measures
| Measure |
2% Rebamipide Group
n=154 Participants
2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
|
|---|---|
|
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
CFB at Week2 (n=154)
|
-2.2 FCS score
Standard Deviation 2.3
|
|
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
CFB at Week4 (n=149)
|
-2.7 FCS score
Standard Deviation 2.4
|
|
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
CFB at Week28 (n=135)
|
-4.1 FCS score
Standard Deviation 2.8
|
|
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
CFB at Week52 (n=127)
|
-4.6 FCS score
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week2, Week4, Week28, Week52LGCS 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).
Outcome measures
| Measure |
2% Rebamipide Group
n=154 Participants
2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
|
|---|---|
|
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
CFB at Week2 (n=154)
|
-2.6 LGCS score
Standard Deviation 3.0
|
|
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
CFB at Week4 (n=149)
|
-3.3 LGCS score
Standard Deviation 3.2
|
|
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
CFB at Week28 (n=135)
|
-5.7 LGCS score
Standard Deviation 4.0
|
|
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
CFB at Week52 (n=127)
|
-6.0 LGCS score
Standard Deviation 3.7
|
Adverse Events
2% Rebamipide Group
Serious events: 6 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2% Rebamipide Group
n=154 participants at risk
2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.65%
1/154 • Number of events 1 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.65%
1/154 • Number of events 1 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/154 • Number of events 1 • 52 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Surgical and medical procedures
Surgical vascular shunt
|
0.65%
1/154 • Number of events 1 • 52 Weeks
|
Other adverse events
| Measure |
2% Rebamipide Group
n=154 participants at risk
2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
|
|---|---|
|
Eye disorders
Abnormal sensation in eye
|
1.9%
3/154 • Number of events 3 • 52 Weeks
|
|
Eye disorders
Blepharitis
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
5.2%
8/154 • Number of events 8 • 52 Weeks
|
|
Eye disorders
Conjunctivitis
|
4.5%
7/154 • Number of events 7 • 52 Weeks
|
|
Eye disorders
Conjunctivitis allergic
|
5.2%
8/154 • Number of events 8 • 52 Weeks
|
|
Eye disorders
Dry eye
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Eye discharge
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Eye disorders
Eye irritation
|
3.9%
6/154 • Number of events 6 • 52 Weeks
|
|
Eye disorders
Eye pain
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Eye disorders
Lacrimation decreased
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Lacrimation increased
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Retinal haemorrhage
|
1.9%
3/154 • Number of events 3 • 52 Weeks
|
|
Eye disorders
Trichiasis
|
5.2%
8/154 • Number of events 8 • 52 Weeks
|
|
Eye disorders
Vision blurred
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Eye disorders
Visual acuity reduced
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Eye disorders
Foreign body sensation in eyes
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Conjunctival hyperaemia
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Eye disorders
Meibomian gland discharge
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Eye pruritus
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Ocular discomfort
|
1.9%
3/154 • Number of events 3 • 52 Weeks
|
|
Eye disorders
Dacryostenosis acquired
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Eye disorders
Corneal disorder
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Eye disorders
Meibomian gland dysfunction
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Gastrointestinal disorders
Dental caries
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/154 • Number of events 3 • 52 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Gastrointestinal disorders
Periodontitis
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Infections and infestations
Cystitis
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Infections and infestations
Dacryocystitis
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Infections and infestations
Gastroenteritis
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
22.1%
34/154 • Number of events 34 • 52 Weeks
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.9%
3/154 • Number of events 3 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.9%
6/154 • Number of events 6 • 52 Weeks
|
|
Investigations
Blood urea increased
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.9%
3/154 • Number of events 3 • 52 Weeks
|
|
Investigations
Glucose urine present
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Investigations
White blood cell count decreased
|
3.9%
6/154 • Number of events 6 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
6/154 • Number of events 6 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Nervous system disorders
Dizziness
|
2.6%
4/154 • Number of events 4 • 52 Weeks
|
|
Nervous system disorders
Dysgeusia (bitter taste)
|
13.6%
21/154 • Number of events 21 • 52 Weeks
|
|
Nervous system disorders
Headache
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.9%
6/154 • Number of events 6 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.2%
5/154 • Number of events 5 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
|
Vascular disorders
Peripheral coldness
|
1.3%
2/154 • Number of events 2 • 52 Weeks
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place