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AzTrials

GlaucomaPhase 3NCT00383019

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

A Phase 3 study testing Xalatan and Xalacom in people with Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Glaucoma, Ocular Hypertension
What is being tested?
Xalatan and Xalacom
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
54 sitesJapan
Study dates
14 Nov 2006to 1 Oct 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

Japan54 sites

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Tokyo Metropolitan Police Hospital

    Chiyoda City, Tokyo, 102-8161

  • Ochanomizu Inoue Eye Clinic

    Chiyoda-ku, Tokyo, 101-0062

  • Hanasaki Eye Clinic

    Fuji, Shizuoka, 416-0952

  • Nakajima Eye Clinic

    Fuji, Shizuoka, 419-0204

  • Lumine Hatano Eye Clinic

    Fujisawa, Kanagawa, 251-0052

  • Hayashi Eye Hospital

    Fujuoka, 812-0011

  • Hayashi Tennjin Eye Clinic

    Fukuoka, 810-0002

  • Ohshima Hospital of Opthalmology

    Fukuoka, 812-0036

  • Kato Eye Clinic

    Fukuoka, 814-0133

  • Gifu University Hospital

    Gifu, 501-1194

  • Keio Hachioji Matsumoto Eye Clinic

    Hachiōji, Tokyo, 192-0046

  • Manabe Clinic

    Hamura, Tokyo, 205-0001

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Nomura Eye Clinic

    Ichinomiya, Aichi-ken, 491-0837

  • Matsusura Eye Clinic

    Ichinomiya, Aichi-ken, 491-0858

  • Tanino clinic

    Kamakura, Kanagawa, 248-0035

  • Kanazawa university hospital

    Kanazawa, Ishikawa-ken, 920-0934

  • Tokyo Sugita Eye Center

    Katsushika-ku, Tokyo, 125-0041

  • Kiyosenomori Hospital

    Kiyose, Tokyo, 204-0021

  • Miyazaki Eye Clinic

    Koto-ku, Tokyo, 136-0076

  • Kobe University Hospital

    Koube, Hyōgo, 650-0017

  • Hayashi Eye Clinic

    Kumagaya, Saitama, 360-0843

  • Takase Ganka Tairamachi Clinic

    Meguro City, Tokyo, 152-0032

  • Ohashi Eye Clinic

    Meguro-ku, Tokyo, 153-0043

  • Yoshimura Eye & Internal Medical Clinic

    Mishima, Shizuoka, 411-0824

  • Miyata Eye Hospital

    Miyakonojō, Miyazaki, 885-0051

  • Kunitoshi Eye Clinic

    Musashino, Tokyo, 180-0004

  • Shimizu Eye Clinic

    Musashino, Tokyo, 180-0022

  • Yasuma Eye Clinic

    Nagoya, Aichi-ken, 460-0011

  • TANABE Eye Clinic

    Nagoya, Aichi-ken, 466-0054

  • Suzuki Eye Clinic

    Nagoya, Aichi-ken, 467-0806

  • Mitsuhashi Eye Clinic

    Narashino, Chiba, 275-0016

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8122

  • Nishi Eye Hospital

    Osaka, 537-0025

  • Adachi Eye Clinic

    Osaka, 557-0044

  • Osaka Welfare Pension Hospital

    Osaka

  • WAKABA Eye Clinic

    Ōta-ku, Tokyo, 144-052

  • Aoki eye clinic

    Sagamihara, Kanagawa, 228-0806

  • Ohtsuka Eye Clinic

    Sapporo, Hokkaido, 001-0016

  • Sasamoto Eye Clinic

    Sapporo, Hokkaido, 001-0039

  • Ohyachi Kyouritsu Eye Clinic

    Sapporo, Hokkaido, 004-0041

  • Kaimeido Eye Clinic

    Sapporo, Hokkaido, 062-0020

  • Fujita Eye Clinic

    Sapporo, Kokkaido, 003-0062

  • Seijo Clinic

    Setagaya City, Tokyo, 157-0066

  • Yotsuya Shirato Ganka

    Shinjuku, Tokyo, 160-0004

  • Nanba Opthalmology

    Shizuoka, 420-0833

  • Sugita Eye Hospital

    Sugita

  • Muramatsu Ganka Clinic

    Susono, Shizuoka, 410-1102

  • Tachihi Bill clinic

    Tachikawa, Tokyo, 190-0003

  • Ueno Eye Clinic

    Taito-ku, Tokyo, 110-015

  • Hiraoka Eye Clinic

    Tokorozawa, Saitama, 359-1116

  • Chihara Eye Clinic

    Uji, Kyoto, 611-0043

  • Kikuna Yuda Eye Clinic

    Yokohama, Kanagawa, 222-0011

Other trials in Japan

About this study

Official title: 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)

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.

Being tested
Xalatan, Xalacom
Medical subject headings
Glaucoma, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XalatanDrug

    latanoprost 0.005%, one rop once daily in evening

  • XalacomDrug

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

Study groups in NCT00383019
Study groupRoleWhat they receive
XalatanExperimentalNot described
Receives: Drug: Xalatan
XalacomExperimentalNot described
Receives: Drug: Xalacom

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Value at Week 8 minus value at baseline

    Measured: Baseline to Week 8

Secondary outcomes (8)

  1. Change of IOP From Baseline to Week 4

    Value at Week 4 minus value at baseline

    Measured: Baseline to Week 4

  2. Number of Subjects With an IOP of <=15 mmHg at Week 8

    Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8

    Measured: Week 8

  3. Number of Subjects With an IOP of <=16 mmHg at Week 8

    Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8

    Measured: Week 8

  4. Percent Change of IOP From Baseline to Week 8

    Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100

    Measured: Baseline to Week 8

  5. Number of Subjects With an IOP of <=18 mmHg at Week 8

    Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8

    Measured: Week 8

  6. Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8

    Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline

    Measured: Baseline to Week 8

  7. Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8

    Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline

    Measured: Baseline to Week 8

  8. Number of Subjects With an IOP of <=17 mmHg at Week 8

    Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2006 (estimated)
  2. Study start14 Nov 2006
  3. Primary completion1 Oct 2007
  4. Study completion1 Oct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00383019
Sponsor's protocol ID
A6641050
Status last verified
Aug 2021
First submitted
29 Sep 2006
Last updated
8 Sep 2021
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xalatan and Xalacom in people with Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Intraocular Pressure (IOP) From Baseline to Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00383019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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