A Phase 3 interventional study of OPC-1085EL ophthalmic solution and Carteolol long-acting ophthalmic solution in Glaucoma and Ocular Hypertension, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-28.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 193 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Once daily
Drug: OPC-1085EL ophthalmic solution
Once daily
Drug: Carteolol long-acting ophthalmic solution
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
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
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
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
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
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
| Milestone | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|
| Started | 78 | 78 | 37 |
| Completed | 76 | 76 | 37 |
| Not completed | 2 | 2 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
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.
| mmHg | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution |
|---|---|---|
| Decrease From Baseline in Intraocular Pressure at Week 8 Predose | 3.5 (3.1 to 3.9) | 1.6 (1.2 to 2.0) |
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.
| mmHg | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution |
|---|---|---|
| Intraocular Pressure at Week 8 Predose | 16.3 ± 0.2 | 18.2 ± 0.2 |
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.
| mmHg | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution |
|---|---|---|
| Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 15.7 ± 0.2 | 17.8 ± 0.2 |
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.
| mmHg | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution |
|---|---|---|
| Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 15.2 ± 0.2 | 17.9 ± 0.3 |
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.
| mmHg | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution |
|---|---|---|
| Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration | 2.9 (2.5 to 3.3) | 0.8 (0.4 to 1.2) |
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.
| mmHg | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration | 3.0 (2.5 to 3.6) | 0.3 (-0.3 to 0.8) |
Collected over From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPC-1085EL Ophthalmic Solution | — | 0/78 (0%) | 21/78 (26.9%) |
| Carteolol Long-acting Ophthalmic Solution | — | 1/78 (1.3%) | 3/78 (3.8%) |
| Carteolol and Latanoprost Ophthalmic Solution | — | 0/37 (0%) | 4/37 (10.8%) |
| Event | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|
| Subdural haematomaInjury, poisoning and procedural complications | 0/78 | 1/78 | 0/37 |
| Event | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|
| Conjunctival hyperaemiaEye disorders | 2/78 | 1/78 | 2/37 |
| Eye painEye disorders | 3/78 | 0/78 | 0/37 |
| Eye irritationEye disorders | 2/78 | 0/78 | 1/37 |
| Ocular hyperaemiaEye disorders | 2/78 | 0/78 | 1/37 |
| NasopharyngitisInfections and infestations | 2/78 | 2/78 | 0/37 |
| Abnormal sensation in eyeEye disorders | 2/78 | 0/78 | 0/37 |
| BlepharitisEye disorders | 2/78 | 0/78 | 0/37 |
| Punctate keratitisEye disorders | 2/78 | 0/78 | 0/37 |
| Foreign body sensation in eyesEye disorders | 2/78 | 0/78 | 0/37 |
| Eye pruritusEye disorders | 2/78 | 0/78 | 0/37 |
| Age, Categorical(Participants) | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 42 | 24 | 115 |
| >=65 years | 29 | 36 | 13 | 78 |
| Age, Continuous(years) | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution | Total |
|---|---|---|---|---|
| Mean | 57.9 ± 12.1 | 60.6 ± 10.6 | 56.6 ± 12.6 | 58.8 ± 11.7 |
| Sex: Female, Male(Participants) | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution | Total |
|---|---|---|---|---|
| Female | 40 | 39 | 21 | 100 |
| Male | 38 | 39 | 16 | 93 |
| Region of Enrollment(participants) | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution | Total |
|---|---|---|---|---|
| Japan | 78 | 78 | 37 | 193 |
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Otsuka Pharmaceutical Co., Ltd.