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Prospective, multicentric, double-masked clinical study to compare the efficacy and safety of Ganfort and Duotrav in primary open angle and pseudoexfoliative glaucoma patients previously treated with Xalacom - ND

Prospective, multicentric, double-masked clinical study to compare the efficacy and safety of Ganfort and Duotrav in primary open angle and pseudoexfoliative glaucoma patients previously treated with Xalacom - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004023-38-IT
Enrollment
124
Registered
2007-11-29
Start date
2007-07-30
Completion date
Unknown
Last updated
2012-10-16

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

Conditions

Glaucoma MedDRA version: 9.1 Level: LLT Classification code 10018304 Term: Glaucoma

Interventions

Trade Name: GANFORT Pharmaceutical Form: Eye drops, solution INN or Proposed INN: TIMOLOLO MALEATO/BIMATOPROST CAS Number: 26921-17-5 Concentration unit: µg/ml microgram(s)/millilitre Concentration ty

Sponsors

IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patient is suffering from POAG or PEX (If the patient has glaucoma and high IOP in both eyes, both eyes will be treated but the worst eye chose for the statistical analysis). Glaucoma definition is based on the European Glaucoma Society Guidelines. The patient is on either a non-fixed combination of Xalatan and Timolol for at least 3 months or on Xalacom for at least 6 month The patient has an IOP=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not at least 18 years old Beta blockers are contraindicated Closed/barely open anterior chamber angles or history of acute angle closure. Ocular surgery or argon laser trabeculoplasty within the last three months. Ocular inflammation/infection occurring within three months prior to pre-trial visit. Concominant topical ocular medication that can interfere with study medication Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective is to compare the area under the distribution of the IOP daily curve (measured at 8.00, 11.00, 14.00, 17.00, 20.00 o?clock) after 3 months of treatment with Ganfort and with Duotrav.;Secondary Objective: Daily IOP changes after 3 month of treatment IOP changes from baseline after 1 month of treatment IOP changes after switching from the first to the second treatment Response to treatment in POAG and PXF subgroups. Reaching of specific target IOP thresholds. Safety;Primary end point(s): to compare the area under the distribution of the IOP daily curve (measured at 8.00, 11.00, 14.00, 17.00, 20.00 o?clock) after 3 months of treatment—

Countries

Austria, Germany, Italy

Outcome results

None listed

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