Comparison study of dexamethasone eye drops and mitomycin in glaucoma surgery.

Comparison of non-MMC trabeculectomy and dexamethasone nanoparticles eye drops with MMC trabeculectomy and Maxidex®

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001093-16-IS

Enrollment

Unknown

Registered

2013-06-18

Start date

2013-07-16

Completion date

Unknown

Last updated

2016-09-19

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

Conditions

Anti-inflammatory treatment post trabeculectomy

Interventions

Product Name: DexNP Product Code: DexCD1.5 Pharmaceutical Form: Eye drops, suspension Trade Name: Maxidex Pharmaceutical Form: Eye drops, suspension Trade Name: Mitomycin powder for infusion Pharmac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Inclusion criteria - Patients with a diagnosis of glaucoma that are scheduled to undergo glaucoma surgery - 18-85 years of age - Signed informed consent form 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: • Exclusion criteria - Any active ocular disease or infection - Those allergic to study medications - Pregnant women and breastfeeding women - Those unable to understand the informed consent - Those that have participated in any clinical study for the last six months

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of the trial is to evaluate and compare rate of complete success after trabeculectomy when patient receive two different formulation of dexamethasone. Half of the patients will receive DexNP post-op and no mitomycinC during surgery as is conventional. The other half of the patients will receive Maxidex post-op and conventional mitomycinC during surgery.;Secondary Objective: Secondary objective is to evaluate the rate of relative success and monitor IOP values, interventions as well as safety.;Primary end point(s): Primary outcome measures: o Rates of complete success, i.e. difference between target pressure and IOP measured at three, six and 12 months without IOP-lowering medication or post-operative intervention. ;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months	—

Measure

Time frame

Main Objective: Main objective of the trial is to evaluate and compare rate of complete success after trabeculectomy when patient receive two different formulation of dexamethasone. Half of the patients will receive DexNP post-op and no mitomycinC during surgery as is conventional. The other half of the patients will receive Maxidex post-op and conventional mitomycinC during surgery.;Secondary Objective: Secondary objective is to evaluate the rate of relative success and monitor IOP values, interventions as well as safety.;Primary end point(s): Primary outcome measures: o Rates of complete success, i.e. difference between target pressure and IOP measured at three, six and 12 months without IOP-lowering medication or post-operative intervention. ;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures: o Relative success, i.e. difference between target pressure and IOP measured at three, six and 12 months with or without added post-operative medications or intervention. o Absolute IOP values o Incidence of additional medical and surgical interventions (need of post-operative medications, needling, laser suture lysis and needling revision) o Relative reduction of IOP compared with baseline o Safety ;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, 3 months, 6 months, 1 year.	—

Measure

Time frame

Secondary end point(s): Secondary outcome measures: o Relative success, i.e. difference between target pressure and IOP measured at three, six and 12 months with or without added post-operative medications or intervention. o Absolute IOP values o Incidence of additional medical and surgical interventions (need of post-operative medications, needling, laser suture lysis and needling revision) o Relative reduction of IOP compared with baseline o Safety ;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, 3 months, 6 months, 1 year.

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Countries

Iceland

Contacts

Public ContactPrincipal Investigator

Oculis ehf.

einarste@landspitali.is

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026