Fact CheckerSign in

NCT05857267CompletedPhase 4

Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety

Phase IV, Multicenter, Double-blind, Randomized, Controlled, Parallel-group, Trial to Evaluate the Efficacy and Safety of Dozolamide 2%/Timolol 0,5% PF vs Dorzolamide 2%/Timolol 0,5% BAK-preserved in OAG or OH

Source: ClinicalTrials.gov · Last updated 6 Nov 2024

Brief summary (registry, in English)

The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
84 (actual)
First submitted
30 Mar 2023
Start date
7 Mar 2023
Primary completion date
4 Nov 2024
Lead sponsor
Laboratorios Poen
NCT number
NCT05857267

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 84
  • From 7 Mar 2023 to the primary completion date, 4 Nov 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors
  • Patients who underwent kerato-refractive laser procedures, cornea or corneal surface surgery, including, but not limited to, LASIK and PRK, within 6 months prior to the baseline visit.
  • Patients who have undergone a laser procedure or intraocular surgery or extraocular in either eye within 6 months prior to the baseline visit.

Other illness

  • Patient with severe respiratory diseases (asthma, COPD and other bronchospactic diseases).
  • Patient with cardiovascular diseases (Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock).
  • Severe renal impairment (CrCl \<30 mL/min)
  • Progressive diseases of the retina other than glaucoma
  • Ocular surface syndrome other than Ocular Surface disease
  • Eyelid disorder
  • Patient with autoinmune diseases
  • Patients with known hypersensitivity to any of the components of bothdrugs under study.

Age

  • Women of childbearing age who are not using a contraceptive method.

Other

  • Inflammation and/or infecctions active
  • Patient that requires another antigluacomatous eye drop other than fixed combination of Dorzolamide/Timolol
  • Patients who use regularly lubricant eye drops
  • Patient who use regularly contact lenses
  • Patients with severe central visual field loss in either eye based onclinical judgment of the investigator. For the Humphrey and Octopus perimeters, the severe loss The visual field is defined as a sensitivity less than or equal to 10 dB in at least two(2) of the four (4) visual field test points closest to the fixation point
  • Pregnant or lactating women.

Who the study is looking for

  • Older than 18 years old
  • Patients with POAG and OH
  • PIO \< 20 mmHg
  • Under treatment with Dorzolamide + Timolol BAK preserved at least 6 month after
  • OSDI \> 13 \& one of these ocular signs (BUT \<6sec or Schirmer test \< 5 mm/5min or corneal staining positive)
  • Corneal thickness between 520-580 um.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Consultorios de Oftalmología
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Gonella Oftalmólogos
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
Centro Diagnóstico Dr. Gentile
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
Consultorio Dr. Peyret
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AireArgentinaUnknown status
Centro oftalmológico Dr. Casiraghi & asociados
Coordinator of this site? Confirm its status
Ciudad Autónoma de Buenos AireArgentinaUnknown status
Clínica de Ojos Dr. Nano
Coordinator of this site? Confirm its status
OlivosArgentinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.