Skip to main content
OpenTrials
Completed

NCT Number: NCT00383019

A Study Comparing 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Matsusura Eye Clinic, Ichinomiya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xalatan

Drug

latanoprost 0.005%, one rop once daily in evening

Xalacom

Drug

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

Primary outcomes

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

    Time frame: Baseline to Week 8

    Value at Week 8 minus value at baseline

Secondary outcomes

  1. Change of IOP From Baseline to Week 4

    Time frame: Baseline to Week 4

    Value at Week 4 minus value at baseline

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

    Time frame: Week 8

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

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

    Time frame: Week 8

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

  4. Percent Change of IOP From Baseline to Week 8

    Time frame: Baseline to Week 8

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

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

    Time frame: Week 8

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

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

    Time frame: Baseline to Week 8

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

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

    Time frame: Baseline to Week 8

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

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

    Time frame: Week 8

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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 2, 2006
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.