NCT01655758

Brief Summary

This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

July 21, 2012

Last Update Submit

August 1, 2012

Conditions

Ocular Hypertension

Keywords

glaucoma24-hour IOPoutflow drugsinflow drugs

Outcome Measures

Primary Outcomes (1)

  • change in the mean IOP at the end of each phase vs baseline, and change of IOP at the different time points of the 24-hour phasing with respect to baseline

    Goldmann Applanation tonometry (GAT): 2 readings averaged. If \>2 mmHg difference between the two, a further reading will be performed. GAT will be adopted during the day, and performed at the slit lamp in sitting position. Tonopen: 4 readings averaged. Tonopen will be used during the night, and the measurements will be perfomred on patients laying in bed in supine position.

    IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.

Secondary Outcomes (1)

  • visual field

    visual field (24/2 SITA) will be performed at screening and at the end of the study (i.e. upon completion of the last cross-over arm, 540 days after baseline)

Study Arms (5)

timolol

ACTIVE COMPARATOR

60-day treatment phase with 0.5% timolol eyedrops, b.i.d.

Drug: 0.5% timolol

'timolol-dorzolamide fixed combination'

ACTIVE COMPARATOR

60-day treatment phase with the fixed combination of 0.5% timolol-2% dorzolamide, eyedrops, b.i.d.

Drug: timolol-dorzolamide fixed combination

xalatan

ACTIVE COMPARATOR

60-day treatment phase with 0.005% latanoprost, eyedrops, QD

Drug: Latanoprost

travatan

ACTIVE COMPARATOR

60-day treatment phase with 0.004% travoprost, eyedrops, QD

Drug: Travoprost

lumigan

ACTIVE COMPARATOR

60-day treatment phase with 0.03% bimatoprost, eyedrops, QD

Drug: Bimatoprost

Interventions

0.5% timololDRUG
Also known as: timoptol (MSD)
timolol
timolol-dorzolamide fixed combinationDRUG
Also known as: cosopt (MSD)
'timolol-dorzolamide fixed combination'
LatanoprostDRUG
Also known as: xalatan (pfizer)
xalatan
TravoprostDRUG
Also known as: travatan (Alcon)
travatan
BimatoprostDRUG
Also known as: lumigan (Allergan)
lumigan

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IOP \> 22 mmHg and \< 30 mmHg on at least three readings on separate days ,
  • Open angle on gonioscopy,
  • CCT \> 550 m,
  • optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,
  • normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),
  • Age \> 40 and \< 70 years,
  • refraction between - 5 and + 2 dyopters,
  • best corrected visual acuity better than 0.2 LogMAR,

You may not qualify if:

  • PEX
  • PDS
  • ocular comorbidiities other than refractive problems and/or mild dry eye
  • history of diabetes
  • treatment with systemic beta blockers and steroids
  • previous treatment with ocular hypotensive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Parma, 43100, Italy

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma

Interventions

Timololdorzolamide-timolol combinationLatanoprostTravoprostmethylacetyleneBimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • STEFANO GANDOLFI, MD

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of ophthalmology and chairman,

Study Record Dates

First Submitted

July 21, 2012

First Posted

August 2, 2012

Study Start

January 1, 2002

Primary Completion

December 1, 2003

Study Completion

February 1, 2004

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

IT(1)