Efficacy and Tolerability of Xalatan in Patients

NCT00950690 | Completed Results

• 1 other identifier: A6111128
• Study Type: observational
• Target: 1,289
• Locations: 3 countries
• Sites: 3

Brief Summary

Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.

Conditions

Glaucoma; Ocular Hypertension

Keywords

observational safety study

Outcome Measures

Primary Outcomes (2)

• Intraocular Pressure

  Intraocular pressure was measured at each visit

  Screening, 10 days, 4 weeks and 12 weeks after beginning treatment

• Humphrey Perimetry Visual Field

  Analysis of visual field deficits for abnormalities.

  Visits 1 and 4

Study Arms (1)

Study Drug - Xalatan 0.005% eye drops

Drug: Xalatan 0.005% eye drops

Interventions

Xalatan 0.005% eye drops DRUG

ophthalmic solution dosed once daily for 3 months

Also known as: latanoprost

Study Drug - Xalatan 0.005% eye drops

Eligibility Criteria

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

Study Population

adults with glauocma or ocular hypertension

You may qualify if:

• Patient with ocular hypertension at least 22mg Hg
• Patient must be over 18 years old

You may not qualify if:

• None listed in the protocol

Sponsors & Collaborators

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

Study Sites (3)

Pfizer Investigational Site

Alexandria, Egypt

Location

Pfizer Investigational Site

Jeddah, Saudi Arabia

Location

Pfizer Investigational Site

Umm Al Quwain City, United Arab Emirates

Location

Related Links

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

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Latanoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Limitations and Caveats

Efficacy data were not summarized or analyzed because data collection did not permit clear identification of IOP \& visual field data in this non-monitored observational study. Consequently, data were not sufficiently interpretable.

Results Point of Contact

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

ClinicalTrials.govCallCenter@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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: August 3, 2009
• Study Start: July 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 25, 2021
• Results First Posted: August 3, 2009

Record last verified: 2011-02

Locations

SA (1); EG (1); AE (1)