Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

NCT00486252 | Completed Results

• 1 other identifier: A6111138
• Study Type: observational
• Target: 996
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months

Conditions

Glaucoma,Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP): Baseline to Month 3

  Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

  Baseline, Month 3

Secondary Outcomes (2)

• Percentage Change in Intraocular Pressure (IOP)

  Month 1, Month 3

• Categorized Percentage Change in Intraocular Pressure (IOP)

  Month 1, Month 3

Other Outcomes (1)

• Change in Intraocular Presssure (IOP): Baseline to Month 1

  Baseline, Month 1

Study Arms (1)

This is N/A due to the above description.

This is N/A due to the above description.

Other: Observational

Interventions

Observational OTHER

This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.

This is N/A due to the above description.

Eligibility Criteria

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

Study Population

outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension

You may qualify if:

• Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
• Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
• Visual acuity (best corrected) equal to or better than 6/6

You may not qualify if:

• closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
• history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
• ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
• other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

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, Open-Angle; Ocular Hypertension

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 14, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 1, 2021
• Results First Posted: July 16, 2009

Record last verified: 2009-11