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

NCT05857267 | Completed Phase 4 DMC

• 1 other identifier: ANTIGLAULC01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Symptoms

  OSDI questtionarie

  Change from baseline in OSDI score at 24 weeks

Secondary Outcomes (7)

• Intraocular preassure

  Change from baseline in PIO (mmHg) at 24 weeks

• Break-up Time

  Change from baseline BUT (seconds) at 24 weeks

• SCHIRMER-ITEST

  Change from baseline Shirmer test (mm) at 24 weeks

• Conjunctival Hyperemia

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

• Satisfaction questionnaire

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

Other Outcomes (11)

• Superficial corneal epithelium density

  Change from baseline superficial corneal epithelium density at 48 weeks

• Basal corneal epithelium density

  Change from baseline basal corneal epithelium density at 48 weeks

• Corneal Estroma reflectivity

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

Study Arms (2)

Dorzolamide+Timolol PF

EXPERIMENTAL

Glaucotensil TD LC, Laboratorios Poen

Drug: Dorzolamide / Timolol Ophthalmic Solution

Dorzolamide + Timolol BAK

EXPERIMENTAL

Glaucotensil TD, Laboratorios Poen

Drug: dorzolamide/timolol

Interventions

Dorzolamide / Timolol Ophthalmic Solution DRUG

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

Also known as: Glaucotensil TD LC

Dorzolamide+Timolol PF

dorzolamide/timolol DRUG

Dorzolamide-timolol BAK-preserved fixed combination

Also known as: Glaucotensil TD

Dorzolamide + Timolol BAK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Poen: lead

Study Sites (6)

Clínica de Ojos Dr. Nano

Olivos, Buenos Aires, B1636CSS, Argentina

Location

Consultorio Dr. Peyret

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1007ABK, Argentina

Location

Gonella Oftalmólogos

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1122AAK, Argentina

Location

Centro Diagnóstico Dr. Gentile

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1425AYA, Argentina

Location

Centro oftalmológico Dr. Casiraghi & asociados

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., C1124, Argentina

Location

Consultorios de Oftalmología

Buenos Aires, C1425FAB, Argentina

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

dorzolamide; dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 12, 2023
• Study Start: March 7, 2023
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

AR (6)