A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
- Registration Number
- NCT00383019
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.
- History of no-response to timolol
- History of trabeculectomy
- History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xalatan Xalatan - Xalacom Xalacom -
- Primary Outcome Measures
Name Time Method Change of Intraocular Pressure (IOP) From Baseline to Week 8 Baseline to Week 8 Value at Week 8 minus value at baseline
- Secondary Outcome Measures
Name Time Method 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 <=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 of <=16 mmHg at Week 8 Week 8 Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8
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
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 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 of <=18 mmHg at Week 8 Week 8 Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8
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
Trial Locations
- Locations (54)
Nomura Eye Clinic
🇯🇵Ichinomiya, Aichi, Japan
Matsusura Eye Clinic
🇯🇵Ichinomiya, Aichi, Japan
Yasuma Eye Clinic
🇯🇵Nagoya, Aichi, Japan
TANABE Eye Clinic
🇯🇵Nagoya, Aichi, Japan
Suzuki Eye Clinic
🇯🇵Nagoya, Aichi, Japan
Mitsuhashi Eye Clinic
🇯🇵Narashino, Chiba, Japan
Ohtsuka Eye Clinic
🇯🇵Sapporo, Hokkaido, Japan
Sasamoto Eye Clinic
🇯🇵Sapporo, Hokkaido, Japan
Ohyachi Kyouritsu Eye Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kaimeido Eye Clinic
🇯🇵Sapporo, Hokkaido, Japan
Scroll for more (44 remaining)Nomura Eye Clinic🇯🇵Ichinomiya, Aichi, Japan