NCT00619034

Brief Summary

The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 29, 2010

Status Verified

December 1, 2010

Enrollment Period

3.3 years

First QC Date

February 7, 2008

Last Update Submit

December 28, 2010

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Diameter of retinal blood vessels

    one year

Secondary Outcomes (1)

  • Influence on retinal blood flow in diabetes

    one year

Study Arms (3)

latanoprost

EXPERIMENTAL

Medical intervention cross-over

Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)

diclofenac

ACTIVE COMPARATOR

medical intervention

Drug: Diclofenac

dorzolamide

EXPERIMENTAL

dorzolamide eyedrops twice daily in one week

Drug: Dorzolamide

Interventions

Latanoprost, diclofenac and dorzolamide (eyedrops)DRUG

1 eyedrop twice daily in one week

Also known as: Xalatan, Voltaren ophtha, Trusopt
latanoprost
DiclofenacDRUG

dicolfenac eyedrops twice daily i one eye

Also known as: Voltaren ophtha
diclofenac
DorzolamideDRUG

dorzolamide eyedrops twice daily, in one eye for one week

Also known as: Trusopt eyedrops
dorzolamide

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes type 1 with moderate diabetic retinopathy/healthy
  • Blood pressure \< 135/85 mmHg

You may not qualify if:

  • Eye disease (excluding diabetic retinopathy)
  • Allergic
  • Kidney disease
  • Liver disease
  • Severe asthma
  • Heart disease
  • Hypertension arterial
  • Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide
  • Pregnant and breastfeeding women and women who don't use secure contraception
  • Persons who can't do without contact lens in the treated eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

LatanoprostDiclofenacdorzolamideOphthalmic Solutions

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Kathrine K Tilma, MD

    Department of Ophthalmology - Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 20, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 29, 2010

Record last verified: 2010-12

Locations

DK(1)