NCT00796198

Brief Summary

Hypothesis: Studies suggest that patients with low diastolic velocity and high resistivity index in the ophthalmic artery had more progressive visual fields, the investigators hypothesize therefore that addition of Cosopt to Latanoprost could improve ocular diastolic perfusion pressure (ODPP). Objective: To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 25, 2008

Status Verified

November 1, 2008

Enrollment Period

6 months

First QC Date

November 21, 2008

Last Update Submit

November 24, 2008

Conditions

Glaucoma

Keywords

GlaucomaIntraocular pressureOcular diastolic perfusion pressureDorzolamide/timolol Fixed combinationHeidelberg Retina Flowmeter

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of Cosopt on ODPP in patients not adequately controlled with latanoprost alone

    baseline, at 1 and 3 months

Secondary Outcomes (1)

  • To evaluate the effects of Cosopt on IOP lowering in patients not adequately controlled with latanoprost alone.

    baseline, at 1 and 3 months

Study Arms (2)

Xalatan+Cosopt

ACTIVE COMPARATOR

Cosopt will be added to Xalatan when Xalatan is effective but not sufficient to reach the target pressure (Add group) (n = 25)

Drug: Xalatan+CosoptDrug: Xalatan

Xalatan

ACTIVE COMPARATOR

when Xalatan is effective and sufficient to reach the target pressure no other medication will be added (control group) (n = 25)

Drug: Xalatan

Interventions

Xalatan+CosoptDRUG

Xalatan ophthalmic solution one drop at 10pm + Cosopt ophthalmic solution one drop at 8am and one drop at 8 pm

Xalatan+Cosopt
XalatanDRUG

Xalatan ophthalmic solution one drop at 10pm

XalatanXalatan+Cosopt

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • POAG patients with a pattern deviation score (or its equivalent) ranging from 2.5 dB to 6.0 dB will be included in the study. This will ensure that patients with early/mid-stage glaucoma will be homogeneously collected; avoids advanced glaucoma in which OBF may behave as a different disease state.
  • Best-corrected visual acuity will be of 0.5 or better with an ametropia \<5D - Dioptric transparency, non smokers.
  • Age will be between 45 and 65 years.

You may not qualify if:

  • Normal tension glaucoma, ocular hypertension, cardiovascular and/or metabolic diseases (known to affect blood flow, as diabetes and polycythemia)
  • Visual field defects other than glaucoma; use of vasoactive and/or anti-hypertensive drugs (systemic beta-blocker), use of acetazolamide
  • Hypersensibility and/or contraindications to any of the molecules studied
  • Previous ocular surgery
  • Pregnant or nursing women and use of one of drugs for erectile dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Bari

Bari, 70124, Italy

Location

University of Chieti

Chieti, 66100, Italy

Location

University of Genova

Genova, 16132, Italy

Location

University of Siena

Siena, 53100, Italy

Location

University of Turin

Turin, 10143, Italy

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Teresa Rolle, MD, Assistent Professor

    University of Turin, Department of Clinical Physiopathology, Section of Ophthalmology, Eye Clinic

    PRINCIPAL INVESTIGATOR

  • Teresa Rolle, MD, Assistent Professor

    University of Turin, Department of Clinical Physiopathology-Section of Ophthalmology-Eye Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Rolle, MD

CONTACT

00390115666032teresa.rolle@unito.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

December 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

November 25, 2008

Record last verified: 2008-11

Locations

IT(5)