Trial Outcomes & Findings for Exploratory Study of OPC-12759 Ophthalmic Suspension (NCT NCT01493180)
NCT ID: NCT01493180
Last Updated: 2015-03-10
Results Overview
Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, 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 at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Basekine, 4 weeks
Results posted on
2015-03-10
Participant Flow
Participant milestones
| Measure |
OPC-12759 Ophthalmic Suspension
OPC-12759 ophthalmic suspension 2%
|
Sodium Hyaluronate Ophthalmic Solution
Sodium hyaluronate ophthalmic solution 0.1%
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploratory Study of OPC-12759 Ophthalmic Suspension
Baseline characteristics by cohort
| Measure |
OPC-12759 Ophthalmic Suspension
n=51 Participants
OPC-12759 ophthalmic suspension 2%
|
Sodium Hyaluronate Ophthalmic Solution
n=51 Participants
Sodium hyaluronate ophthalmic solution 0.1%
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 17.9 • n=93 Participants
|
54.5 years
STANDARD_DEVIATION 20.9 • n=4 Participants
|
54.7 years
STANDARD_DEVIATION 19.3 • n=27 Participants
|
|
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
|
31 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
51 participants
n=93 Participants
|
51 participants
n=4 Participants
|
102 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Basekine, 4 weeksKeratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, 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 at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.
Outcome measures
| Measure |
OPC-12759 Ophthalmic Suspension
n=51 Participants
OPC-12759 ophthalmic suspension 2%
|
Sodium Hyaluronate Ophthalmic Solution
n=51 Participants
Sodium hyaluronate ophthalmic solution 0.1%
|
|---|---|---|
|
Change in the Keratoconjunctival Staining Score From Baseline
|
-3.4 scores on a scale
Standard Deviation 2.7
|
-3.1 scores on a scale
Standard Deviation 2.4
|
Adverse Events
OPC-12759 Ophthalmic Suspension
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Sodium Hyaluronate Ophthalmic Solution
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-12759 Ophthalmic Suspension
n=51 participants at risk
OPC-12759 ophthalmic suspension 2%
|
Sodium Hyaluronate Ophthalmic Solution
n=51 participants at risk
Sodium hyaluronate ophthalmic solution 0.1%
|
|---|---|---|
|
Infections and infestations
Meningitis
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
Other adverse events
| Measure |
OPC-12759 Ophthalmic Suspension
n=51 participants at risk
OPC-12759 ophthalmic suspension 2%
|
Sodium Hyaluronate Ophthalmic Solution
n=51 participants at risk
Sodium hyaluronate ophthalmic solution 0.1%
|
|---|---|---|
|
Eye disorders
Chalazion
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
5.9%
3/51 • Number of events 3 • 4 weeks
|
5.9%
3/51 • Number of events 3 • 4 weeks
|
|
Eye disorders
Corneal deposits
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Eye disorders
Corneal infiltrates
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Eye disorders
Eyelid oedema
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Eye disorders
Keratitis
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Eye disorders
Punctate keratitis
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Eye disorders
Trichiasis
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Eye disorders
Vision blurred
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Investigations
Blood potassium decreased
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Investigations
Blood potassium increased
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Investigations
Blood urea increased
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Investigations
Intraocular pressure increased
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
Dysgeusia (bitter taste)
|
7.8%
4/51 • Number of events 4 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord inflammation
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/51 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 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