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

• Sponsor: Laboratorios Poen (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05857267
• Collaborator: (none)
• Enrollment: 84
• Locations: 6
• Arms: 2
• Anticipated Duration (Months): 18.3
• Patients Per Site: 14
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: Dorzolamide / Timolol Ophthalmic Solution; Drug: dorzolamide/timolol	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Mar 7, 2023
• Anticipated Primary Completion Date: Mar 15, 2024
• Anticipated Study Completion Date: Sep 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dorzolamide+Timolol PF Glaucotensil TD LC, Laboratorios Poen	Drug: Dorzolamide / Timolol Ophthalmic Solution; Dorzolamide-timolol fixed combination in a preservative-free multidose device; Other Names: Glaucotensil TD LC
Experimental: Dorzolamide + Timolol BAK Glaucotensil TD, Laboratorios Poen	Drug: dorzolamide/timolol; Dorzolamide-timolol BAK-preserved fixed combination; Other Names: Glaucotensil TD

Outcome Measures

Primary Outcome Measures

1. Ocular Surface Disease Symptoms [Change from baseline in OSDI score at 24 weeks]

   OSDI questtionarie

Secondary Outcome Measures

1. Intraocular preassure [Change from baseline in PIO (mmHg) at 24 weeks]

   Intraocular preassure (PIO) by GAT

2. Break-up Time [Change from baseline BUT (seconds) at 24 weeks]

   Break-up Time (BUT)

3. SCHIRMER-ITEST [Change from baseline Shirmer test (mm) at 24 weeks]

   Schirmer test without anesthesia

4. Conjunctival Hyperemia [Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks]

   Conjunctival Hyperemia

5. Satisfaction questionnaire [Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale]

   Satisfaction questionnaire

6. Best corrected visual acuity [Change from baseline visual acuity at 24 weeks]

   snellen scale 20/20

7. Treatment preference [Treatment preference with respect previous treatment at Week 24]

   Treatment preference

Other Outcome Measures

1. Superficial corneal epithelium density [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 [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 [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 [Change from baseline corneal nerve density at 48 weeks]

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

5. Neuroma density [Change from baseline neuroma density at 48 weeks]

   Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2

6. Dendrite density [Change from baseline dendrite density at 48 weeks]

   Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2

7. Corneal nerve tortuosity [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 [Change from baseline endothelial cell count at 48 weeks]

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

9. Conjuctival epithelium density [Change from baseline conjuctival epithelium density at 48 weeks]

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

10. Goblett cell density [Change from baseline goblett cell density at 48 weeks]

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

11. Inflamatory infiltrates [Change from baseline in inflamatory infiltrates at 48 weeks]

    Description of presence or absence of inflamtory cells on conjuntiva

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica de Ojos Dr. Nano	Olivos	Buenos Aires	Argentina	B1636CSS
2	Consultorio Dr. Peyret	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aires	Argentina	C1007ABK
3	Gonella Oftalmólogos	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aires	Argentina	C1122AAK
4	Centro Diagnóstico Dr. Gentile	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aires	Argentina	C1425AYA
5	Centro oftalmológico Dr. Casiraghi & asociados	Ciudad Autónoma de Buenos Aire	Ciudad Autónoma De Buenos Aires	Argentina	C1124
6	Consultorios de Oftalmología	Ciudad autónoma de Buenos Aires		Argentina	C1425FAB

Sponsors and Collaborators

• Laboratorios Poen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratorios Poen
• ClinicalTrials.gov Identifier: NCT05857267
• Other Study ID Numbers: ANTIGLAULC01
• First Posted: May 12, 2023
• Last Update Posted: May 12, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle; Timolol; Dorzolamide; Ophthalmic Solutions

Study Results

No Results Posted as of May 12, 2023