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OpenTrials
Completed

NCT Number: NCT05857267

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clínica de Ojos Dr. Nano, Olivos, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or corneal staining positive)
  • Corneal thickness between 520-580 um.

Exclusion criteria

  • 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
  • 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 combination of 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 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.
  • 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
  • Patients with known hypersensitivity to any of the components of bothdrugs under study.
  • Pregnant or lactating women.
  • Women of childbearing age who are not using a contraceptive method.

Treatment and study plan

Dorzolamide / Timolol Ophthalmic Solution

Drug

Dorzolamide-timolol fixed combination in a preservative-free multidose device

Other names: Glaucotensil TD LC

dorzolamide/timolol

Drug

Dorzolamide-timolol BAK-preserved fixed combination

Other names: Glaucotensil TD

Primary outcomes

  1. Ocular Surface Disease Symptoms

    Time frame: Change from baseline in OSDI score at 24 weeks

    OSDI questtionarie

Secondary outcomes

  1. Intraocular preassure

    Time frame: Change from baseline in PIO (mmHg) at 24 weeks

    Intraocular preassure (PIO) by GAT

  2. Break-up Time

    Time frame: Change from baseline BUT (seconds) at 24 weeks

    Break-up Time (BUT)

  3. SCHIRMER-ITEST

    Time frame: Change from baseline Shirmer test (mm) at 24 weeks

    Schirmer test without anesthesia

  4. Conjunctival Hyperemia

    Time frame: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks

    Conjunctival Hyperemia

  5. Satisfaction questionnaire

    Time frame: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale

    Satisfaction questionnaire

  6. Best corrected visual acuity

    Time frame: Change from baseline visual acuity at 24 weeks

    snellen scale 20/20

  7. Treatment preference

    Time frame: Treatment preference with respect previous treatment at Week 24

    Treatment preference

Other outcomes

  1. Superficial corneal epithelium density

    Time frame: Change from baseline superficial corneal epithelium density at 48 weeks

    Superficial corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2

  2. Basal corneal epithelium density

    Time frame: Change from baseline basal corneal epithelium density at 48 weeks

    Basal corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2

  3. Corneal Estroma reflectivity

    Time frame: Change from baseline in the grade of corneal estroma reflectivity at 48 weeks specify by 4 grade scale reported by Martone et al. .

    Corneal Estroma reflectivity analyzed by confocal microscopy expresed by 5-point scale of grade

  4. Corneal nerve density

    Time frame: Change from baseline corneal nerve density at 48 weeks

    Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2

  5. Neuroma density

    Time frame: Change from baseline neuroma density at 48 weeks

    Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2

  6. Dendrite density

    Time frame: Change from baseline dendrite density at 48 weeks

    Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2

  7. Corneal nerve tortuosity

    Time frame: Change from baseline in the grade of corneal nerve tortousity at 48 weeksusing a 5 point scale reported by Oliviera-Soto et al.

    Corneal nerve tortuosity analyzed by confocal microscopy expresed by 5-point scale of grade

  8. Endothelial cell density

    Time frame: Change from baseline endothelial cell count at 48 weeks

    endothelial cell density analyzed by confocal microscopy expresed by cells/mm2

  9. Conjuctival epithelium density

    Time frame: Change from baseline conjuctival epithelium density at 48 weeks

    Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2

  10. Goblett cell density

    Time frame: Change from baseline goblett cell density at 48 weeks

    Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2

  11. Inflamatory infiltrates

    Time frame: Change from baseline in inflamatory infiltrates at 48 weeks

    Description of presence or absence of inflamtory cells on conjuntiva

Sponsors and collaborators

Lead sponsor

Laboratorios Poen

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 12, 2023
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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