Glaucoma, Open-AnglePhase 4NCT05857267
Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety
A Phase 4 study testing Dorzolamide / Timolol Ophthalmic Solution and dorzolamide/timolol in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Laboratorios Poen at 6 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Dorzolamide / Timolol Ophthalmic Solution and dorzolamide/timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesArgentina
- Study dates
- 7 Mar 2023to 4 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Argentina6 sites
Consultorios de Oftalmología
Buenos Aires, C1425FAB
Consultorio Dr. Peyret
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1007ABK
Gonella Oftalmólogos
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1122AAK
Centro Diagnóstico Dr. Gentile
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1425AYA
Centro oftalmológico Dr. Casiraghi & asociados
Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., C1124
Clínica de Ojos Dr. Nano
Olivos, Buenos Aires, B1636CSS
About this study
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
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
- Being tested
- Dorzolamide / Timolol Ophthalmic Solution, dorzolamide/timolol
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorzolamide / Timolol Ophthalmic SolutionDrug
Also called Glaucotensil TD LC
Dorzolamide-timolol fixed combination in a preservative-free multidose device
dorzolamide/timololDrug
Also called Glaucotensil TD
Dorzolamide-timolol BAK-preserved fixed combination
| Study group | Role | What they receive |
|---|---|---|
| Dorzolamide+Timolol PF | Experimental | Glaucotensil TD LC, Laboratorios Poen Receives: Drug: Dorzolamide / Timolol Ophthalmic Solution |
| Dorzolamide + Timolol BAK | Experimental | Glaucotensil TD, Laboratorios Poen Receives: Drug: dorzolamide/timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Symptoms
OSDI questtionarie
Measured: Change from baseline in OSDI score at 24 weeks
Secondary outcomes (7)
Intraocular preassure
Intraocular preassure (PIO) by GAT
Measured: Change from baseline in PIO (mmHg) at 24 weeks
Break-up Time
Break-up Time (BUT)
Measured: Change from baseline BUT (seconds) at 24 weeks
SCHIRMER-ITEST
Schirmer test without anesthesia
Measured: Change from baseline Shirmer test (mm) at 24 weeks
Conjunctival Hyperemia
Conjunctival Hyperemia
Measured: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
Satisfaction questionnaire
Satisfaction questionnaire
Measured: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
Best corrected visual acuity
snellen scale 20/20
Measured: Change from baseline visual acuity at 24 weeks
Treatment preference
Treatment preference
Measured: Treatment preference with respect previous treatment at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start7 Mar 2023
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Poen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857267
- Sponsor's protocol ID
- ANTIGLAULC01
- Status last verified
- Nov 2024
- First submitted
- 30 Mar 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05857267
- Acronym / sponsor ID
- ANTIGLAULC01
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Laboratorios PoenIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorzolamide+Timolol PF | Experimental | Drug: Dorzolamide / Timolol Ophthalmic SolutionGlaucotensil TD LC, Laboratorios Poen |
| Dorzolamide + Timolol BAK | Experimental | Drug: dorzolamide/timololGlaucotensil TD, Laboratorios Poen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorzolamide / Timolol Ophthalmic SolutionAlso: Glaucotensil TD LCDorzolamide-timolol fixed combination in a preservative-free multidose device | Drug | Dorzolamide+Timolol PF |
| dorzolamide/timololAlso: Glaucotensil TDDorzolamide-timolol BAK-preserved fixed combination | Drug | Dorzolamide + Timolol BAK |
Primary outcome
Ocular Surface Disease Symptoms
Time frame: Change from baseline in OSDI score at 24 weeks
OSDI questtionarie
7 secondary outcomes
Intraocular preassure
Time frame: Change from baseline in PIO (mmHg) at 24 weeks
Break-up Time
Time frame: Change from baseline BUT (seconds) at 24 weeks
SCHIRMER-ITEST
Time frame: Change from baseline Shirmer test (mm) at 24 weeks
Conjunctival Hyperemia
Time frame: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
Satisfaction questionnaire
Time frame: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
Best corrected visual acuity
Time frame: Change from baseline visual acuity at 24 weeks
Treatment preference
Time frame: Treatment preference with respect previous treatment at Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dorzolamide / Timolol Ophthalmic Solution and dorzolamide/timolol in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Laboratorios Poen at 6 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Symptoms (time frame: Change from baseline in OSDI score at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.