A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00856622

Collaborator

(none)

436

Enrollment

Locations

Arms

Duration (Months)

11.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Glaucoma Open-angle Glaucoma	Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5% Drug: timolol 0.5% ophthalmic solution Drug: latanoprost 0.005% ophthalmic solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

436 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Aug 1, 1997

Actual Primary Completion Date :

Jun 1, 1999

Actual Study Completion Date :

Jun 1, 1999

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5%	Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5% one drop in the morning and placebo in the evening Other Names: xalacom, xalcom
Active Comparator: timolol 0.5% ophthalmic solution one drop in the morning and evening	Drug: timolol 0.5% ophthalmic solution one drop in the morning and evening Other Names: timoptic
Active Comparator: latanoprost 0.005% ophthalmic solution placebo in the morning and latanoprost .005% in the evening	Drug: latanoprost 0.005% ophthalmic solution placebo in the morning and latanoprost .005% in the evening Other Names: xalatan

Arm

Intervention/Treatment

Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5%

Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%

one drop in the morning and placebo in the evening

Other Names:

xalacom, xalcom

Active Comparator: timolol 0.5% ophthalmic solution

one drop in the morning and evening

Drug: timolol 0.5% ophthalmic solution

one drop in the morning and evening

Other Names:

timoptic

Active Comparator: latanoprost 0.005% ophthalmic solution

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

Drug: latanoprost 0.005% ophthalmic solution

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

Other Names:

xalatan

Outcome Measures

Primary Outcome Measures

To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. [6 months]

Secondary Outcome Measures

To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26 [6 Months]
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [6 Months]
To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [6 Months]
To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 [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]
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 [6 Months]
To follow the safety variables throughout the study periods. [6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 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.
Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (two 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.
Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
Pregnancy
Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
Inability to adhere to treatment/visit plan.
Have participated in any other clinical study within one month prior to pre-study visit.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Aachen	Germany
2	Pfizer Investigational Site	Aalen	Germany
3	Pfizer Investigational Site	Ahaus	Germany	48683
4	Pfizer Investigational Site	Alzey	Germany	55232
5	Pfizer Investigational Site	Aschaffenburg	Germany	63739
6	Pfizer Investigational Site	Bad Abbach	Germany	93077
7	Pfizer Investigational Site	Berlin	Germany	13088
8	Pfizer Investigational Site	Coesfeld	Germany	48653
9	Pfizer Investigational Site	Dillingen	Germany	89407
10	Pfizer Investigational Site	Eitorf	Germany	53783
11	Pfizer Investigational Site	Erlangen	Germany	91052
12	Pfizer Investigational Site	Essen	Germany	45147
13	Pfizer Investigational Site	Freiburg	Germany	79106
14	Pfizer Investigational Site	Freising	Germany	85354
15	Pfizer Investigational Site	Fulda	Germany
16	Pfizer Investigational Site	Greifswald	Germany	17489
17	Pfizer Investigational Site	Gummersbach	Germany	51643
18	Pfizer Investigational Site	Hannover	Germany
19	Pfizer Investigational Site	Hirschaid	Germany	96114
20	Pfizer Investigational Site	Iserlohn	Germany	58638
21	Pfizer Investigational Site	Koblenz	Germany	56068
22	Pfizer Investigational Site	Leonberg	Germany	71229
23	Pfizer Investigational Site	Leverkusen	Germany	51373
24	Pfizer Investigational Site	Mainz	Germany	55116
25	Pfizer Investigational Site	Mainz	Germany	55124
26	Pfizer Investigational Site	Mainz	Germany	55131
27	Pfizer Investigational Site	Muenchen	Germany	80336
28	Pfizer Investigational Site	Muenchen	Germany	81925
29	Pfizer Investigational Site	Mülheim	Germany	45481
30	Pfizer Investigational Site	Münster	Germany	48165
31	Pfizer Investigational Site	Offenbach	Germany	63065
32	Pfizer Investigational Site	Osnabrueck	Germany	49076
33	Pfizer Investigational Site	Parsberg	Germany	92331
34	Pfizer Investigational Site	Siegburg	Germany	53721
35	Pfizer Investigational Site	Sulzbach	Germany	66280
36	Pfizer Investigational Site	Trier	Germany	54290
37	Pfizer Investigational Site	Weiden	Germany	92637