A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

A 8-WEEK, RANDOMIZED, DOUBLE-MASKED, PARALLEL GROUP, PHASE III STUDY COMPARING THE EFFICACY AND SAFETY OF XALACOM AND XALATAN IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA (POAG) OR OCULAR HYPERTENSION (OH)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00383019

Enrollment

300

Registered

2006-10-02

Start date

2006-11-14

Completion date

2007-10-01

Last updated

2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Brief summary

This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.

Interventions

DRUGXalacom

latanoprost 0.005% adn timolol 0.5%, one drop, once daily

DRUGXalatan

latanoprost 0.005%, one rop once daily in evening

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

Exclusion criteria

* History of no-response to timolol * History of trabeculectomy * History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

Design outcomes

Primary

Measure	Time frame	Description
Change of Intraocular Pressure (IOP) From Baseline to Week 8	Baseline to Week 8	Value at Week 8 minus value at baseline

Secondary

Measure	Time frame	Description
Change of IOP From Baseline to Week 4	Baseline to Week 4	Value at Week 4 minus value at baseline
Number of Subjects With an IOP of <=16 mmHg at Week 8	Week 8	Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8
Percent Change of IOP From Baseline to Week 8	Baseline to Week 8	Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100
Number of Subjects With an IOP of <=15 mmHg at Week 8	Week 8	Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8
Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8	Baseline to Week 8	Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline
Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8	Baseline to Week 8	Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline
Number of Subjects With an IOP of <=17 mmHg at Week 8	Week 8	Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8
Number of Subjects With an IOP of <=18 mmHg at Week 8	Week 8	Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8

Countries

Japan

Participant flow

Recruitment details

55 centers in Japan

Pre-assignment details

300 subjects were treated with Xalatan in Run-in period. (Run-in period: subjects treated with Xalatan (0.005% latanoprost eye drop), one drop, once daily in the evening (20:00-23:00).) Of these, 289 subjects were assigned to groups (144 in KP2035 group and 145 in Xalatan group).

Participants by arm

Arm	Count
KP2035 Group Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).	144
Xalatan Group Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).	145
Total	289

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	5	1
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	KP2035 Group	Xalatan Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	66 Participants	68 Participants	134 Participants
Age, Categorical Between 18 and 65 years	78 Participants	77 Participants	155 Participants
Region of Enrollment Japan	144 Participants	145 Participants	289 Participants
Sex: Female, Male Female	70 Participants	74 Participants	144 Participants
Sex: Female, Male Male	74 Participants	71 Participants	145 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 144	0 / 145
other Total, other adverse events	51 / 144	29 / 145
serious Total, serious adverse events	1 / 144	2 / 145

Outcome results

Primary

Change of Intraocular Pressure (IOP) From Baseline to Week 8

Value at Week 8 minus value at baseline

Time frame: Baseline to Week 8

Population: The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
KP2035 Group	Change of Intraocular Pressure (IOP) From Baseline to Week 8	-2.59 mmHg
Xalatan Group	Change of Intraocular Pressure (IOP) From Baseline to Week 8	-1.62 mmHg

Secondary

Change of IOP From Baseline to Week 4

Value at Week 4 minus value at baseline

Time frame: Baseline to Week 4

Population: ITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
KP2035 Group	Change of IOP From Baseline to Week 4	-2.50 mmHg
Xalatan Group	Change of IOP From Baseline to Week 4	-1.17 mmHg

Secondary