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

Condition(s) targeted: Ocular Hypertension; Glaucoma

Intervention: latanoprost 0.005% (Drug); fixed combination latanoprost-timolol (Drug); timolol 0.5% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: A 6-Month, Randomized, Double-Masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-Month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups

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

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

To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52

To follow the safety variables throughout the study periods.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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). Exclusion Criteria:

- 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.

Pfizer Investigational Site, Anaheim, California 92801, United States

Pfizer Investigational Site, Anaheim, California 92807, United States

Pfizer Investigational Site, Sacramento, California 95823, United States

Pfizer Investigational Site, Sacramento, California 95819, United States

Pfizer Investigational Site, San Francisco, California 94115, United States

Pfizer Investigational Site, Boulder, Colorado 80304-3573, United States

Pfizer Investigational Site, Denver, Colorado 80210, United States

Pfizer Investigational Site, Largo, Florida 34640, United States

Pfizer Investigational Site, Tampa, Florida 33613, United States

Pfizer Investigational Site, Atlanta, Georgia 30322, United States

Pfizer Investigational Site, Atlanta, Georgia 30342, United States

Pfizer Investigational Site, Atlanta, Georgia 30349, United States

Pfizer Investigational Site, East Point, Georgia 30223, United States

Pfizer Investigational Site, Griffin, Georgia 30223, United States

Pfizer Investigational Site, Morrow, Georgia 30260, United States

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Wheaton, Illinois 60187, United States

Pfizer Investigational Site, Elkhart, Indiana 46515, United States

Pfizer Investigational Site, Mishawaka, Indiana 46545, United States

Pfizer Investigational Site, South Bend, Indiana 46601, United States

Pfizer Investigational Site, South Bend, Indiana 46617, United States

Pfizer Investigational Site, Iowa City, Iowa 52245, United States

Pfizer Investigational Site, Louisville, Kentucky 40207, United States

Pfizer Investigational Site, Baltimore, Maryland 21201, United States

Pfizer Investigational Site, Owings Mills, Maryland 21117, United States

Pfizer Investigational Site, Boston, Massachusetts 02111, United States

Pfizer Investigational Site, Golden Valley, Minnesota 55422, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55421, United States

Pfizer Investigational Site, Kansas City, Missouri 64114, United States

Pfizer Investigational Site, Kansas City, Missouri 64111, United States

Pfizer Investigational Site, Warrenburg, Missouri 64093, United States

Pfizer Investigational Site, Concord, New Hampshire 03301, United States

Pfizer Investigational Site, South Plainfield, New Jersey 07080, United States

Pfizer Investigational Site, Charlotte, North Carolina 28260, United States

Pfizer Investigational Site, Charlotte, North Carolina 28210, United States

Pfizer Investigational Site, Charlotte, North Carolina 28204, United States

Pfizer Investigational Site, Matthews, North Carolina 28105, United States

Pfizer Investigational Site, Monroe, North Carolina 28112, United States

Pfizer Investigational Site, Portland, Oregon 97201, United States

Pfizer Investigational Site, Portland, Oregon 97210, United States

Pfizer Investigational Site, Wyomissing, Pennsylvania 19610, United States

Pfizer Investigational Site, Charleston, South Carolina 29412, United States

Pfizer Investigational Site, Mount Pleasant, South Carolina 29464-3245, United States

Pfizer Investigational Site, Memphis, Tennessee 38119, United States

Pfizer Investigational Site, Austin, Texas 78731-4941, United States

Pfizer Investigational Site, Galveston, Texas 77555-1141, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Charlottesville, Virginia, United States

Pfizer Investigational Site, Richmond, Virginia 23219, United States

Pfizer Investigational Site, Richmond, Virginia 23235, United States

Pfizer Investigational Site, Tacoma, Washington 98431, United States

Pfizer Investigational Site, Madison, Wisconsin 53705, United States

Pfizer Investigational Site, Madison, Wisconsin 53715, United States

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

Starting date: July 1997
Last updated: March 5, 2009