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Estudio unicéntrico de fase II, doble ciego, randomizado, comparando doxiciclina administrada oralmente frente a placebo en pacientes con pterigión. Single center, double blind, randomized clinical trial comparing orally administered doxycycline against placebo in pterygium patients. - PTERDOXY

Estudio unicéntrico de fase II, doble ciego, randomizado, comparando doxiciclina administrada oralmente frente a placebo en pacientes con pterigión. Single center, double blind, randomized clinical trial comparing orally administered doxycycline against placebo in pterygium patients. - PTERDOXY

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-007178-39-ES
Enrollment
Unknown
Registered
2010-02-19
Start date
2009-09-25
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacientes con pterigión primario no intervenido. Patients suffering from untreated primary pterygium.

Interventions

Sponsors

Center for Biomedical Research of La Rioja (CIBIR)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients suffering from pterygium. Must be 18 years old or older. Able to comply with treatment and follow-up visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients younger than 18. Pregnant women, lactating mothers, and women trying to get pregnant. Allergies to tetracyclines. Patients taking drugs incompatible with tetracyclines. Serious cardiac or cerebrovascular disease during 6 months previous to the study. Patients that cannot be regularly followed because of psycological, social, familiar, or geographical reasons.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: We will also study whether doxycycline treatment reduces the number of secondary growths following resection of pterygium. A genomic/proteomic study will be performed on the tissue specimens obtained from chirurgical resection of pterygium.;Main Objective: The main objective of the study is to reduce pterygium growth using a pharmacological treatment and reduce the number of pterygium patients that need to be subjected to surgery.;Primary end point(s): Photographs of the eye affected by pterygium will be taken during the first visit and at the second visit following 4 weeks of treatment. The area covered by pterygium will be quantified. The quotient between the surface in the second visit and the area of the first visit will provide a growth or diminution ratio. This ratio will be the primary end point of the study.

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 24, 2026