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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00800267
Collaborator
(none)
418
Enrollment
53
Locations
3
Arms
23
Duration (Months)
7.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: latanoprost 0.005%
  • Drug: fixed combination latanoprost-timolol
  • Drug: timolol 0.5%
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
418 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. A Multicenter Study in the United States
Study Start Date :
Jul 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: fixed combination latanoprost-timolol
one drop in the morning and placebo in the evening
Active Comparator: latanoprost 0.005%

Drug: latanoprost 0.005%
placebo in the morning and latanoprost .005% in the evening
Active Comparator: Timolol - 0.5%

Drug: timolol 0.5%
one drop in the morning and evening

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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 Outcome Measures

  1. 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]

  2. To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [6 months]

  3. To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [6 months]

  4. To describe the IOP development from baseline to Week 26 for all treatment groups [6 months]

  5. 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]

  6. To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 [6 months]

  7. 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:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Anaheim California United States 92801
2 Pfizer Investigational Site Anaheim California United States 92807
3 Pfizer Investigational Site Sacramento California United States 95819
4 Pfizer Investigational Site Sacramento California United States 95823
5 Pfizer Investigational Site San Francisco California United States 94115
6 Pfizer Investigational Site Boulder Colorado United States 80304-3573
7 Pfizer Investigational Site Denver Colorado United States 80210
8 Pfizer Investigational Site Largo Florida United States 34640
9 Pfizer Investigational Site Tampa Florida United States 33613
10 Pfizer Investigational Site Atlanta Georgia United States 30322
11 Pfizer Investigational Site Atlanta Georgia United States 30342
12 Pfizer Investigational Site Atlanta Georgia United States 30349
13 Pfizer Investigational Site East Point Georgia United States 30223
14 Pfizer Investigational Site Griffin Georgia United States 30223
15 Pfizer Investigational Site Morrow Georgia United States 30260
16 Pfizer Investigational Site Chicago Illinois United States 60612
17 Pfizer Investigational Site Wheaton Illinois United States 60187
18 Pfizer Investigational Site Elkhart Indiana United States 46515
19 Pfizer Investigational Site Mishawaka Indiana United States 46545
20 Pfizer Investigational Site South Bend Indiana United States 46601
21 Pfizer Investigational Site South Bend Indiana United States 46617
22 Pfizer Investigational Site Iowa City Iowa United States 52245
23 Pfizer Investigational Site Louisville Kentucky United States 40207
24 Pfizer Investigational Site Baltimore Maryland United States 21201
25 Pfizer Investigational Site Owings Mills Maryland United States 21117
26 Pfizer Investigational Site Boston Massachusetts United States 02111
27 Pfizer Investigational Site Golden Valley Minnesota United States 55422
28 Pfizer Investigational Site Minneapolis Minnesota United States 55421
29 Pfizer Investigational Site Kansas City Missouri United States 64111
30 Pfizer Investigational Site Kansas City Missouri United States 64114
31 Pfizer Investigational Site Warrensburg Missouri United States 64093
32 Pfizer Investigational Site Concord New Hampshire United States 03301
33 Pfizer Investigational Site South Plainfield New Jersey United States 07080
34 Pfizer Investigational Site Charlotte North Carolina United States 28204
35 Pfizer Investigational Site Charlotte North Carolina United States 28210
36 Pfizer Investigational Site Charlotte North Carolina United States 28260
37 Pfizer Investigational Site Matthews North Carolina United States 28105
38 Pfizer Investigational Site Monroe North Carolina United States 28112
39 Pfizer Investigational Site Portland Oregon United States 97201
40 Pfizer Investigational Site Portland Oregon United States 97210
41 Pfizer Investigational Site Wyomissing Pennsylvania United States 19610
42 Pfizer Investigational Site Charleston South Carolina United States 29412
43 Pfizer Investigational Site Mount Pleasant South Carolina United States 29464-3245
44 Pfizer Investigational Site Memphis Tennessee United States 38119
45 Pfizer Investigational Site Austin Texas United States 78731-4941
46 Pfizer Investigational Site Galveston Texas United States 77555-1141
47 Pfizer Investigational Site Houston Texas United States 77030
48 Pfizer Investigational Site Charlottesville Virginia United States
49 Pfizer Investigational Site Richmond Virginia United States 23219
50 Pfizer Investigational Site Richmond Virginia United States 23235
51 Pfizer Investigational Site Tacoma Washington United States 98431
52 Pfizer Investigational Site Madison Wisconsin United States 53705
53 Pfizer Investigational Site Madison Wisconsin United States 53715

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00800267
Other Study ID Numbers:
  • 96TIPG005
  • A6641006
First Posted:
Dec 2, 2008
Last Update Posted:
Feb 18, 2021
Last Verified:
Mar 1, 2009
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
glaucoma
ocular hypertension
Fixed combination latanoprost-timolol
latanoprost
timolol
Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Hypertension
Timolol
Latanoprost

Study Results

No Results Posted as of Feb 18, 2021