Trial Outcomes & Findings for Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension (NCT NCT02105272)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

237 participants

Primary outcome timeframe

Baseline, week 8 predose

Results posted on

2015-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	OPC-1085EL Ophthalmic Solution Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution Once daily Latanoprost ophthalmic solution
Overall Study STARTED	118	119
Overall Study COMPLETED	113	116
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	OPC-1085EL Ophthalmic Solution Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution Once daily Latanoprost ophthalmic solution
Overall Study Adverse Event	1	2
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	2	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=118 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=119 Participants Once daily Latanoprost ophthalmic solution	Total n=237 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
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants	69 Participants n=7 Participants	140 Participants n=5 Participants
Age, Categorical >=65 years	47 Participants n=5 Participants	50 Participants n=7 Participants	97 Participants n=5 Participants
Age, Continuous	59.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	60.8 years STANDARD_DEVIATION 11.5 • n=7 Participants	60.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	76 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	43 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Japan	118 participants n=5 Participants	119 participants n=7 Participants	237 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, week 8 predose

Outcome measures

Outcome measures
Measure	OPC-1085EL Ophthalmic Solution n=117 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=118 Participants Once daily Latanoprost ophthalmic solution
Decrease From Baseline in Intraocular Pressure	2.9 mmHg Interval 2.5 to 3.3	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. 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=117 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=118 Participants Once daily Latanoprost ophthalmic solution
Intraocular Pressure at Week 8 Predose	17.1 mmHg Standard Error 0.2	18.4 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. 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=114 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=118 Participants Once daily Latanoprost ophthalmic solution
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration	17.2 mmHg Standard Error 0.2	18.2 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 8hours after IMP administration. 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=88 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=92 Participants Once daily Latanoprost ophthalmic solution
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration	16.7 mmHg Standard Error 0.2	17.4 mmHg Standard Error 0.2

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. 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=114 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=118 Participants Once daily Latanoprost ophthalmic solution
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration	2.1 mmHg Interval 1.7 to 2.4	1.0 mmHg Interval 0.6 to 1.4

SECONDARY outcome

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

Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration. 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=88 Participants Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=92 Participants Once daily Latanoprost ophthalmic solution
Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration	1.7 mmHg Interval 1.3 to 2.1	1.0 mmHg Interval 0.6 to 1.3

Adverse Events

OPC-1085EL Ophthalmic Solution

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Latanoprost Ophthalmic Solution

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OPC-1085EL Ophthalmic Solution n=118 participants at risk Once daily OPC-1085EL ophthalmic solution	Latanoprost Ophthalmic Solution n=119 participants at risk Once daily Latanoprost ophthalmic solution
Infections and infestations Nasopharyngitis	3.4% 4/118 • Number of events 4 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)	5.9% 7/119 • Number of events 8 • From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Investigations Glucose urine present	2.5% 3/118 • 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% 0/119 • 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