Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

NCT01191008 | Completed Results

• 1 other identifier: A6641056
• Study Type: observational
• Target: 661
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Xalacom Regulatory post marketing commitment plan safety

Outcome Measures

Primary Outcomes (2)

• Number of Participants WithTreatment-Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.

  Max 104 weeks

• Clinical Effectiveness Rate

  Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).

  Max 104 weeks

Other Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

  Max 104 weeks

Study Arms (1)

Latan-timolol maleate fixed comb ophthalmic solution

Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution

Interventions

Latanoprost-timolol maleate fixed combination ophthalmic solution DRUG

Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "One drop should be applied to the affected eye(s) once daily".

Also known as: Xalacom

Latan-timolol maleate fixed comb ophthalmic solution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.

You may qualify if:

• Patients need to be administered Xalacom® in order to be enrolled in the surveillance.

You may not qualify if:

• Patients not administered Xalacom®.

Sponsors & Collaborators

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

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Xalacom

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 1, 2023
• Results First Posted: July 17, 2017

Record last verified: 2017-02