Glaucoma, Ocular Hypertension
Conditions
Brief summary
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.
Interventions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension
Exclusion criteria
* Subjects with ocular conditions as defined by the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease From Baseline in Intraocular Pressure at Week 8 Predose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure at Week 8 Predose | 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. |
| Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 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. |
| Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 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. |
| Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 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. |
| Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPC-1085EL Ophthalmic Solution Once daily
OPC-1085EL ophthalmic solution | 78 |
| Carteolol Long-acting Ophthalmic Solution Once daily
Carteolol long-acting ophthalmic solution | 78 |
| Carteolol and Latanoprost Ophthalmic Solution Once daily
Carteolol ophthalmic solution and Latanoprost ophthalmic solution | 37 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution | OPC-1085EL Ophthalmic Solution | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 13 Participants | 29 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 24 Participants | 49 Participants | 115 Participants |
| Age, Continuous | 60.6 years STANDARD_DEVIATION 10.6 | 56.6 years STANDARD_DEVIATION 12.6 | 57.9 years STANDARD_DEVIATION 12.1 | 58.8 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment Japan | 78 participants | 37 participants | 78 participants | 193 participants |
| Sex: Female, Male Female | 39 Participants | 21 Participants | 40 Participants | 100 Participants |
| Sex: Female, Male Male | 39 Participants | 16 Participants | 38 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 78 | 3 / 78 | 4 / 37 |
| serious Total, serious adverse events | 0 / 78 | 1 / 78 | 0 / 37 |
Outcome results
Primary
Decrease From Baseline in Intraocular Pressure at 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.
Time frame: Baseline, Week 8 Predose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OPC-1085EL Ophthalmic Solution | Decrease From Baseline in Intraocular Pressure at Week 8 Predose | 3.5 mmHg |
| Carteolol Long-acting Ophthalmic Solution | Decrease From Baseline in Intraocular Pressure at Week 8 Predose | 1.6 mmHg |
Secondary
Change From Baseline in Intraocular Pressure at 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.
Time frame: Baseline, Week 8 at 8 hours after IMP administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OPC-1085EL Ophthalmic Solution | Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 3.0 mmHg |
| Carteolol Long-acting Ophthalmic Solution | Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 0.3 mmHg |
Secondary
Decrease From Baseline in Intraocular Pressure at 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.
Time frame: Baseline, Week 8 at 2 hours after IMP administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OPC-1085EL Ophthalmic Solution | Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 2.9 mmHg |
| Carteolol Long-acting Ophthalmic Solution | Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 0.8 mmHg |
Secondary
Intraocular Pressure at 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.
Time frame: Week 8 at 2 hours after IMP administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPC-1085EL Ophthalmic Solution | Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 15.7 mmHg | Standard Error 0.2 |
| Carteolol Long-acting Ophthalmic Solution | Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 17.8 mmHg | Standard Error 0.2 |
Secondary
Intraocular Pressure at 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.
Time frame: Week 8 at 8 hours after IMP administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPC-1085EL Ophthalmic Solution | Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 15.2 mmHg | Standard Error 0.2 |
| Carteolol Long-acting Ophthalmic Solution | Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 17.9 mmHg | Standard Error 0.3 |
Secondary
Intraocular Pressure at 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.
Time frame: Week 8 Predose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPC-1085EL Ophthalmic Solution | Intraocular Pressure at Week 8 Predose | 16.3 mmHg | Standard Error 0.2 |
| Carteolol Long-acting Ophthalmic Solution | Intraocular Pressure at Week 8 Predose | 18.2 mmHg | Standard Error 0.2 |