A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800267
First received: November 3, 2008
Last updated: March 5, 2009
Last verified: March 2009
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Purpose
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Hypertension Glaucoma |
Drug: latanoprost 0.005% Drug: fixed combination latanoprost-timolol Drug: timolol 0.5% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To describe the IOP development from baseline to Week 26 for all treatment groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To follow the safety variables throughout the study periods. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 418 |
| Study Start Date: | July 1997 |
| Study Completion Date: | June 1999 |
| Primary Completion Date: | June 1999 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800267
Show 53 Study Locations
Show 53 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00800267 History of Changes |
| Other Study ID Numbers: | 96TIPG005, A6641006 |
| Study First Received: | November 3, 2008 |
| Last Updated: | March 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
glaucoma ocular hypertension Fixed combination latanoprost-timolol latanoprost timolol |
Additional relevant MeSH terms:
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Latanoprost Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 21, 2013