A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

NCT00800267 | Completed Phase 3

• 2 other identifiers: 96TIPG005A6641006
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 53

Brief Summary

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

Conditions

Ocular Hypertension; Glaucoma

Keywords

glaucoma; ocular hypertension; Fixed combination latanoprost-timolol; latanoprost; timolol

Outcome Measures

Primary Outcomes (2)

• The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.

  6 months

• Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.

  6 months

Secondary Outcomes (7)

• To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol

  6 months

• To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26

  6 months

• To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups

  6 months

• To describe the IOP development from baseline to Week 26 for all treatment groups

  6 months

• To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination

  6 months

Study Arms (3)

Fixed combination of latanoprost 0.005% and timolol 0.5%

EXPERIMENTAL

Drug: fixed combination latanoprost-timolol

latanoprost 0.005%

ACTIVE COMPARATOR

Drug: latanoprost 0.005%

Timolol - 0.5%

ACTIVE COMPARATOR

Drug: timolol 0.5%

Interventions

latanoprost 0.005% DRUG

placebo in the morning and latanoprost .005% in the evening

latanoprost 0.005%

fixed combination latanoprost-timolol DRUG

one drop in the morning and placebo in the evening

Fixed combination of latanoprost 0.005% and timolol 0.5%

timolol 0.5% DRUG

one drop in the morning and evening

Timolol - 0.5%

Eligibility Criteria

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

You may qualify if:

• Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
• Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

You may not qualify if:

• History of acute angle closure or closed/barely open anterior chamber angle.
• Current use of contact lenses.
• Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
• Ocular inflammation/infection occurring within three months prior to pre-study visit.
• Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
• Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
• Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
• Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
• Inability to adhere to treatment/visit plan.
• Have participated in any other clinical study within one month prior to pre-study visit.

Sponsors & Collaborators

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

Study Sites (53)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Anaheim, California, 92807, United States

Location

Pfizer Investigational Site

Sacramento, California, 95819, United States

Location

Pfizer Investigational Site

Sacramento, California, 95823, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Boulder, Colorado, 80304-3573, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80210, United States

Location

Pfizer Investigational Site

Largo, Florida, 34640, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33613, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30349, United States

Location

Pfizer Investigational Site

East Point, Georgia, 30223, United States

Location

Pfizer Investigational Site

Griffin, Georgia, 30223, United States

Location

Pfizer Investigational Site

Morrow, Georgia, 30260, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Wheaton, Illinois, 60187, United States

Location

Pfizer Investigational Site

Elkhart, Indiana, 46515, United States

Location

Pfizer Investigational Site

Mishawaka, Indiana, 46545, United States

Location

Pfizer Investigational Site

South Bend, Indiana, 46601, United States

Location

Pfizer Investigational Site

South Bend, Indiana, 46617, United States

Location

Pfizer Investigational Site

Iowa City, Iowa, 52245, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40207, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Owings Mills, Maryland, 21117, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02111, United States

Location

Pfizer Investigational Site

Golden Valley, Minnesota, 55422, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55421, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64111, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64114, United States

Location

Pfizer Investigational Site

Warrensburg, Missouri, 64093, United States

Location

Pfizer Investigational Site

Concord, New Hampshire, 03301, United States

Location

Pfizer Investigational Site

South Plainfield, New Jersey, 07080, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28204, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28260, United States

Location

Pfizer Investigational Site

Matthews, North Carolina, 28105, United States

Location

Pfizer Investigational Site

Monroe, North Carolina, 28112, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97201, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Wyomissing, Pennsylvania, 19610, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29412, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464-3245, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Austin, Texas, 78731-4941, United States

Location

Pfizer Investigational Site

Galveston, Texas, 77555-1141, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Charlottesville, Virginia, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23219, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23235, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98431, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53705, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53715, United States

Location

Related Links

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

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: December 2, 2008
• Study Start: July 1, 1997
• Primary Completion: June 1, 1999
• Study Completion: June 1, 1999
• Last Updated: February 18, 2021

Record last verified: 2009-03

Locations

US (53)