A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01379144
First received: June 20, 2011
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Drug: latanoprost 75 ug
Drug: latanoprost 100 ug
Drug: latanoprost 125 ug
Drug: latanoprost 50 ug
Phase 2

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 4 Week, Dose-Ranging, Multi-Center, Randomized, Double-Masked, Parallel Study Comparing The Efficacy, Safety, And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma Aand Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28). [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline across all clinic visits; comparisons were made by separate analyses for each time point and visit. [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28). [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits. [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: January 2003
Study Completion Date: April 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: latanoprost 75 ug Drug: latanoprost 75 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.

Experimental: latanoprost 100 ug Drug: latanoprost 100 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.

Experimental: latanoprost 125 ug Drug: latanoprost 125 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.

Active Comparator: latanoprost 50 ug Drug: latanoprost 50 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age or older.
  • Primary open angle glaucoma (POAG) or ocular hypertension (OHT) requiring unilateral or bilateral administration of intraocular pressure (IOP) lowering treatment, including patients who were naïve to IOP lowering treatment.
  • IOP between ≥ 24 mmHg and ≤ 36 mmHg in at least one eye at the 8 AM time point at baseline/randomization.

Exclusion Criteria:

  • Closed/barely open anterior chamber angle or a history of acute angle closure.
  • A history of discontinued prostaglandin IOP lowering treatment, unless the reason for discontinuation was participation in a clinical study.
  • Ocular surgery or argon laser trabeculoplasty in one or both eyes within 3 months prior to the screening visit.
  • Use or anticipated requirement during the study of any topical medication that was known to affect IOP.
  • Anticipated need to modify systemic medication known to affect IOP (eg, beta-adrenergic antagonists, alpha-adrenergic agonists, calcium channel blockers, angiotension converting enzyme inhibitors, and angiotension II receptor antagonists) during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379144

Locations
Australia, New South Wales
Eye Associates Pty Limited
Sydney, New South Wales, Australia, 2000
Save Sight Institute
Sydney, New South Wales, Australia, 2000
Australia, South Australia
Royal Adelaide Hospital, North Terrace
Adelaide, South Australia, Australia, 5000
Czech Republic
University Hospital Brno-Bohunice
Brno, Czech Republic, CZ - 62500
Private Ophthalmology, V Hurkach 1296
Prague 5, Czech Republic, 150 00
Institute of Aviation Medicine, Generalal Piky 1
Prague 9, Czech Republic, 160 60
VseobecnBfakultnf nemocnice
Praha 2, Czech Republic, 128 21
Specializovana Glaukomova Poradna, Blanicka 25
Praha 2, Czech Republic, 120 00
France
Hopital Des Armees Laveran
Marseille, France
Hopital De La Timone
Marseille, France
Fondation Adolphe De Rothchild
Paris, France, 75016
Hopital Civil
Strasbourg, France
Greece
Akadimos Ophthalmology Center of Northern Greece
Thessaloniki, Greece
Pakistan
Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital
Lahore, Punjab, Pakistan
Services Hospital Lahore
Lahore, Punjab, Pakistan
Civil Hospital Karachi
Karachi, Sindh, Pakistan
Aga Khan University Hospital Karachi
Karachi, Sindh, Pakistan
Portugal
A.I.B.I.L.I.
Coimbra, Portugal, 3000
Hospital De S. Jose
Lisboa, Portugal
Hospital Pedro Hispano
Matosinhos, Portugal
Thailand
Chulalongkorn Hospital
Bangkok, Thailand
Siriraj Hospital, Ophthalmology
Bangkok, Thailand, 10700
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01379144     History of Changes
Other Study ID Numbers: XALA-0091-166, A6111066
Study First Received: June 20, 2011
Last Updated: June 21, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014