EFFICACY AND SAFETY OF TOPICALLY APPLIED PROSTAGLANDIN ANALOGUE AND CARBONIC ANHYDRASE INHIBITOR FOR THE TREATMENT OF PAEDIATRIC GLAUCOMA REFRACTORY TO SURGICAL PROCEDURES - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004763-19-IT

Enrollment

Unknown

Registered

2009-04-21

Start date

2009-06-03

Completion date

Unknown

Last updated

2017-01-31

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

Conditions

Children affected to primary Paediatric Glaucoma MedDRA version: 9.1 Level: LLT Classification code 10064033 Term: Infantile glaucoma

Interventions

Trade Name: TRUSOPT Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Dorzolamide Concentration unit: % percent Concentration type: equal Concentration number: 2- Trade Name: XALATAN Phar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Children of either sexes, aged 0-12 years - Diagnosis of mono- or bilateral primary OAG - IOP greater than or equal to 22 mmHg and lower than 27 mmHg - Only one previous ocular hypotensive surgical procedure for treatment of glaucoma among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin C) (only for medical treatment at least one month before) - Parent informed consent to data processing (at registration) - Parent informed consent before any study procedure Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma, steroid-induced glaucoma, etc.) - Presence of concomitant abnormalities of the anterior segment of the eye (cataract, irido-corneal disgenesia, congenital ectropion uveae, etc.) - Previous treatment with the study drugs - Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease, renal failure, etc.) that needs treatment with drugs, that could influence IOP (steroids, beta-blockers, ACE-inhibitors diuretics, etc.) - Abnormalities of the cornea that could influence IOP readings (marked cornea edema)

Design outcomes

Primary

Measure	Time frame
Main Objective: The study will assess the ocular hypothensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary PG, refractory to surgical procedures.;Secondary Objective: Safety will be assessed, too.;Primary end point(s): Secondary efficacy endpoint will be the time to treatment failure, calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory. Eyes in which the IOP will be maintained under the 20% decrease cut-off level after 3 years or who will be lost to follow-up will be censored at their last assessment date	—

Measure

Time frame

Main Objective: The study will assess the ocular hypothensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary PG, refractory to surgical procedures.;Secondary Objective: Safety will be assessed, too.;Primary end point(s): Secondary efficacy endpoint will be the time to treatment failure, calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory. Eyes in which the IOP will be maintained under the 20% decrease cut-off level after 3 years or who will be lost to follow-up will be censored at their last assessment date

—

Countries

Italy

Outcome results

None listed

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