A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00751127

Collaborator

(none)

268

Enrollment

Locations

Arms

Duration (Months)

15.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PhXA41 is not inferior to timolol

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Open Angle Glaucoma Ocular Hypertension	Drug: PhXA41 Drug: timolol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

268 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A 6-month, Randomized, Double-masked Comparison of Latanoprost (PhXA41) With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United States.

Study Start Date :

Jan 1, 1993

Actual Primary Completion Date :

Feb 1, 1994

Actual Study Completion Date :

Feb 1, 1994

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Timolol	Drug: timolol One drop in the affected eye twice daily for six months.
Experimental: PhXA41	Drug: PhXA41 One drop in the affected eye once daily for six months.

Arm

Intervention/Treatment

Active Comparator: Timolol

Drug: timolol

One drop in the affected eye twice daily for six months.

Experimental: PhXA41

Drug: PhXA41

One drop in the affected eye once daily for six months.

Outcome Measures

Primary Outcome Measures

to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment. [6 mos]

Secondary Outcome Measures

to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. [6 mos]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
IOP of 22mmHg or higher obtained during the pre-study period.
Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:

3 weeks for B-adrenergic antagonists
2 weeks for adrenergic agonists
5 days for cholinergics and oral carbonic anhydrase inhibitors.

Exclusion Criteria:

History of acute angle closure.
Severe trauma at any time.
Intraocular surgery or argon laser trabeculoplasty within 6 months.
Current use of contact lenses.
History of severe dry eye syndrome.
Ocular inflammation/infection with three months of inclusion.
Any condition preventing reliable applanation tonometry.
Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
Having participated in any other clinical study within the last month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	La Jolla	California	United States	92093-0946
2	Pfizer Investigational Site	Los Angeles	California	United States	90033
3	Pfizer Investigational Site	Gainesville	Florida	United States	32610
4	Pfizer Investigational Site	Chicago	Illinois	United States	60611
5	Pfizer Investigational Site	Chicago	Illinois	United States	60612
6	Pfizer Investigational Site	Louisville	Kentucky	United States	40292
7	Pfizer Investigational Site	Baltimore	Maryland	United States	21209
8	Pfizer Investigational Site	Ann Arbor	Michigan	United States
9	Pfizer Investigational Site	St. Louis	Missouri	United States	63110
10	Pfizer Investigational Site	Omaha	Nebraska	United States	68105
11	Pfizer Investigational Site	River Edge	New Jersey	United States	07661-1931
12	Pfizer Investigational Site	New York	New York	United States	10003
13	Pfizer Investigational Site	New York	New York	United States	10029
14	Pfizer Investigational Site	Portland	Oregon	United States	97210-3049
15	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19107-5599
16	Pfizer Investigational Site	Charleston	South Carolina	United States	29425-0001
17	Pfizer Investigational Site	Madison	Wisconsin	United States	53705-3611