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

Last updated: November 4, 2024
Sponsor: Laboratorios Poen
Overall Status: Completed

Phase

4

Condition

Ocular Hypertension

Glaucoma

Treatment

dorzolamide/timolol

Dorzolamide / Timolol Ophthalmic Solution

Clinical Study ID

NCT05857267
ANTIGLAULC01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 orcorneal staining positive)

  • Corneal thickness between 520-580 um.

Exclusion

Exclusion Criteria:

  • Patient with severe respiratory diseases (asthma, COPD and other bronchospacticdiseases).

  • 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

  • Inflammation and/or infecctions active

  • Ocular surface syndrome other than Ocular Surface disease

  • Eyelid disorder

  • Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors

  • Patient that requires another antigluacomatous eye drop other than fixed combinationof Dorzolamide/Timolol

  • Patients who use regularly lubricant eye drops

  • Patient who use regularly contact lenses

  • Patient with autoinmune diseases

  • Patients who underwent kerato-refractive laser procedures, cornea or corneal surfacesurgery, including, but not limited to, LASIK and PRK, within 6 months prior to thebaseline visit.

  • Patients who have undergone a laser procedure or intraocular surgery or extraocularin either eye within 6 months prior to the baseline visit.

  • Patients with severe central visual field loss in either eye based onclinicaljudgment of the investigator. For the Humphrey and Octopus perimeters, the severeloss The visual field is defined as a sensitivity less than or equal to 10 dB in atleast two(2) of the four (4) visual field test points closest to the fixation point

  • Patients with known hypersensitivity to any of the components of bothdrugs understudy.

  • Pregnant or lactating women.

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

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: dorzolamide/timolol
Phase: 4
Study Start date:
March 07, 2023
Estimated Completion Date:
November 04, 2024

Connect with a study center

  • Clínica de Ojos Dr. Nano

    Olivos, Buenos Aires B1636CSS
    Argentina

    Site Not Available

  • Centro Diagnóstico Dr. Gentile

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires C1425AYA
    Argentina

    Site Not Available

  • Consultorio Dr. Peyret

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires C1007ABK
    Argentina

    Site Not Available

  • Gonella Oftalmólogos

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires C1122AAK
    Argentina

    Site Not Available

  • Centro oftalmológico Dr. Casiraghi & asociados

    Ciudad Autónoma de Buenos Aire, Ciudad Autónoma De Buenos Aires C1124
    Argentina

    Site Not Available

  • Consultorios de Oftalmología

    Ciudad autónoma de Buenos Aires, C1425FAB
    Argentina

    Site Not Available

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