Trial Outcomes & Findings for Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension (NCT NCT02105285)

Results Overview

Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

193 participants

Primary outcome timeframe

Baseline, Week 8 Predose

Results posted on

2015-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	OPC-1085EL Ophthalmic Solution Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution Once daily Carteolol long-acting ophthalmic solution	Carteolol and Latanoprost Ophthalmic Solution Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution
Overall Study STARTED	78	78	37
Overall Study COMPLETED	76	76	37
Overall Study NOT COMPLETED	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	OPC-1085EL Ophthalmic Solution Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution Once daily Carteolol long-acting ophthalmic solution
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPC-1085EL Ophthalmic Solution n=78 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=78 Participants Once daily Carteolol long-acting ophthalmic solution	Carteolol and Latanoprost Ophthalmic Solution n=37 Participants Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution	Total n=193 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	42 Participants n=7 Participants	24 Participants n=5 Participants	115 Participants n=4 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	36 Participants n=7 Participants	13 Participants n=5 Participants	78 Participants n=4 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 12.1 • n=5 Participants	60.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	56.6 years STANDARD_DEVIATION 12.6 • n=5 Participants	58.8 years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	39 Participants n=7 Participants	21 Participants n=5 Participants	100 Participants n=4 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	16 Participants n=5 Participants	93 Participants n=4 Participants
Region of Enrollment Japan	78 participants n=5 Participants	78 participants n=7 Participants	37 participants n=5 Participants	193 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8 Predose

Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=78 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=77 Participants Once daily Carteolol long-acting ophthalmic solution
Decrease From Baseline in Intraocular Pressure at Week 8 Predose	3.5 mmHg Interval 3.1 to 3.9	1.6 mmHg Interval 1.2 to 2.0

SECONDARY outcome

Timeframe: Week 8 Predose

Comparison of each group in intraocular pressure at Week 8 Predose. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=78 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=77 Participants Once daily Carteolol long-acting ophthalmic solution
Intraocular Pressure at Week 8 Predose	16.3 mmHg Standard Error 0.2	18.2 mmHg Standard Error 0.2

SECONDARY outcome

Timeframe: Week 8 at 2 hours after IMP administration

Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=76 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=77 Participants Once daily Carteolol long-acting ophthalmic solution
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration	15.7 mmHg Standard Error 0.2	17.8 mmHg Standard Error 0.2

SECONDARY outcome

Timeframe: Week 8 at 8 hours after IMP administration

Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=62 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=54 Participants Once daily Carteolol long-acting ophthalmic solution
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration	15.2 mmHg Standard Error 0.2	17.9 mmHg Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline, Week 8 at 2 hours after IMP administration

Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=76 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=77 Participants Once daily Carteolol long-acting ophthalmic solution
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration	2.9 mmHg Interval 2.5 to 3.3	0.8 mmHg Interval 0.4 to 1.2

SECONDARY outcome

Timeframe: Baseline, Week 8 at 8 hours after IMP administration

Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=62 Participants Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=54 Participants Once daily Carteolol long-acting ophthalmic solution
Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration	3.0 mmHg Interval 2.5 to 3.6	0.3 mmHg Interval -0.3 to 0.8

Adverse Events

OPC-1085EL Ophthalmic Solution

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Carteolol Long-acting Ophthalmic Solution

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Carteolol and Latanoprost Ophthalmic Solution

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OPC-1085EL Ophthalmic Solution n=78 participants at risk Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=78 participants at risk Once daily Carteolol long-acting ophthalmic solution	Carteolol and Latanoprost Ophthalmic Solution n=37 participants at risk Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	1.3% 1/78 • Number of events 1 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)

Other adverse events

Other adverse events
Measure	OPC-1085EL Ophthalmic Solution n=78 participants at risk Once daily OPC-1085EL ophthalmic solution	Carteolol Long-acting Ophthalmic Solution n=78 participants at risk Once daily Carteolol long-acting ophthalmic solution	Carteolol and Latanoprost Ophthalmic Solution n=37 participants at risk Once daily Carteolol ophthalmic solution and Latanoprost ophthalmic solution
Infections and infestations Nasopharyngitis	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Conjunctival hyperaemia	2.6% 2/78 • Number of events 3 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	1.3% 1/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	5.4% 2/37 • Number of events 3 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Eye irritation	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.7% 1/37 • Number of events 1 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Eye pain	3.8% 3/78 • Number of events 3 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Ocular hyperaemia	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.7% 1/37 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Abnormal sensation in eye	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Blepharitis	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Punctate keratitis	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Foreign body sensation in eyes	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Eye pruritus	2.6% 2/78 • Number of events 2 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/78 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/37 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)

Additional Information

Deputy General Manager, Headquarters of Clinical Development

Otsuka Pharmaceutical Co., Ltd.

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place