NCT00751062

Brief Summary

PhXA41 is not inferior to timolol in reducing intra-ocular pressure

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 1992

Shorter than P25 for phase_3

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1992

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1993

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1993

Completed
14.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
Last Updated

February 2, 2021

Status Verified

September 1, 2008

Enrollment Period

1.1 years

First QC Date

September 10, 2008

Last Update Submit

February 1, 2021

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

open angle glaucoma ocular hypertension

Outcome Measures

Primary Outcomes (1)

  • to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.

    6 mos

Secondary Outcomes (1)

  • to demonstrate the IOP-reducing effect of PhXA41 administered in the morning is equivalent the effect of PhXA41 administered in the evening

    6 mos

Study Arms (2)

Timolol

ACTIVE COMPARATOR
Drug: timolol

PhXA41

EXPERIMENTAL
Drug: PhXA41

Interventions

timololDRUG

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.

Timolol
PhXA41DRUG

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

PhXA41

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
  • Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
  • IOP of 22mmHg or higher obtained during the pre-study period.

You may not qualify if:

  • History of acute angle closure.
  • Severe trauma at any time.
  • Intraocular surgery or argon laser trabeculoplasty within 6 months.
  • Current use of contact lenses.
  • History of severe dry eye syndrome.
  • Any condition preventing reliable applanation tonometry.
  • Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
  • In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
  • Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
  • Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
  • Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
  • Having participated in any other clinical study within the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Pfizer Investigational Site

Hellerup, Denmark

Location

Pfizer Investigational Site

Vejle, Denmark

Location

Pfizer Investigational Site

Oulu, Finland

Location

Pfizer Investigational Site

Bergen, Norway

Location

Pfizer Investigational Site

Oslo, Norway

Location

Pfizer Investigational Site

Trondheim, Norway

Location

Pfizer Investigational Site

Gothenburg, Sweden

Location

Pfizer Investigational Site

Huddinge, 141 86, Sweden

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Pfizer Investigational Site

Lund, Sweden

Location

Pfizer Investigational Site

Malmo, 205 02, Sweden

Location

Pfizer Investigational Site

Umeå, Sweden

Location

Pfizer Investigational Site

Uppsala, Sweden

Location

Related Publications (1)

  • Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.

    PMID: 19427617DERIVED

Related Links

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

TimololLatanoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

November 1, 1992

Primary Completion

December 1, 1993

Study Completion

December 1, 1993

Last Updated

February 2, 2021

Record last verified: 2008-09

Locations

FI(1)DK(2)NO(3)SE(7)