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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

Last updated on November 16, 2019

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Study Location
Eye Associates Pty Limited
Sydney, New South Wales, 2000 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Open Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01379144
Pfizer
Completed
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

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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • 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.

  • 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.

  • 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.

  • 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.

Study Arms  ICMJE
  • Experimental: latanoprost 75 ug
    Intervention: Drug: latanoprost 75 ug
  • Experimental: latanoprost 100 ug
    Intervention: Drug: latanoprost 100 ug
  • Experimental: latanoprost 125 ug
    Intervention: Drug: latanoprost 125 ug
  • Active Comparator: latanoprost 50 ug
    Intervention: Drug: latanoprost 50 ug
Publications *Eveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 ?g/mL to latanoprost 50 ?g/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2011)
282
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2003
Actual Primary Completion DateMarch 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czechia,   France,   Greece,   Pakistan,   Portugal,   Thailand,   United Kingdom
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT01379144
Other Study ID Numbers  ICMJE XALA-0091-166
A6111066
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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