The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
237
Unnamed facility
Kansai Region, Japan
Decrease From Baseline in Intraocular Pressure
Time frame: Baseline, week 8 predose
Intraocular Pressure at 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.
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. 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 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.
Time frame: Week 8 at 8 hours after IMP administration
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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. 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
Decrease 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 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.
Time frame: Baseline, Week 8 at 8 hours after IMP administration