Primary Open-angle GlaucomaNCT04891588
Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD
A study testing Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC) in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
Trial summary
Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic nerve damage and consequent visual loss. In most cases, it is associated with elevated intraocular pressure. If glaucoma left untreated, complete blindness can occur. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 8 Mar 2021to 8 Dec 2021
- Phase
- Interventional
- 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
- patients with open angle galucoma or ocular hypertension that had been controlled (stable IOP <19mmHg) by commercially available preserved PGA -timolol FC for at least 3 months
- Stable visual field (based on at least two reliable visual field tests performed within the last 12 months)
- Central corneal thickness within the range 500-580µm.
- mild to moderate hyperaemia based on MacMonnies (scores 1 and 2)
Who cannot join
- Best-corrected visual acuity (BCVA) 0,1 or lower
- Severe visual field defects (MD 12 dB or higher)
- Any intraocular surgery (other than filtration surgery performed at least 6 months before screening)
- Any ocular surface abnormality preventing accurate IOP measurement
- Acute ocular inflammation
- Contact lens wearers
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Klinički bolnički centar Zagreb
Zagreb, 10000
Kristina Mikina, 00385-01-2388430, predstojnik.oci@kbc-zagreb.hr
Varja Ivković, 00385-01-2388423, varja.ivkovic@kbc-zagreb.hr
About this study
Official title: Evaluation of Glaucoma or Ocular Hypertension Patients With Pre-existing Ocular Surface Disease Switched From a Preserved Prostaglandin Analog - Timolol Fixed Combination to a Preservative - Free Latanoprost - Timolol Fixed Combination
Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic nerve damage and consequent visual loss. In most cases, it is associated with elevated intraocular pressure. If glaucoma left untreated, complete blindness can occur. Prostaglandin analog- timolol FCs are common glaucoma therapy because these drugs have been shown to effectively lower intraocular pressure (IOP). It is also known that chronic use of preservatives in the drops leads to ocular surface disease (OSD) which can lead to low tolerability of prescribed drops and gaps in the dosing regimen.
The purpose of this study is to investigate whether drug preservative elimination results in reduction of OSD symptoms and signs as well as improvement of latanoprost-timolol FC local tolerability in the treatment of glaucoma and ocular hypertension.
In this trial, on each visit (V1, V2 and V3) following tests will be used: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test - TBUT). Visual Analog Scale (VAS) will be used for a subjective assessment of drug tolerability. The association of quality of life and dry eye symptoms in participants will be measured by the Ocular Surface Disease Index (OSDI) questionnaire.
Read the detailed description
Glaucoma is a heterogeneous group of chronic ocular diseases characterized by a loss of the retinal nerve fiber layer and consequent damage to the optic nerve head. Increased intraocular pressure is considered a major risk factor for development of the disease. If glaucoma left untreated, visual field impairment and complete visual loss can occur. Due to the effective reduction of intraocular pressure, prostaglandin analog-timolol fixed combinations (FC) are considered to be a mainstay in glaucoma treatment. However, it is well known that long-term use of preservatives in glaucoma drops leads to ocular surface disease (OSD) which causes low tolerability and nonadherence with prescribed therapy.
The study is designed to determine whether switching from a preserved prostaglandin analog- timolol FC to an equally effective and safe preservative - free latanoprost - timolol FC can result in alleviation or elimination of OSD and improvement of local tolerability.
In this study, on each visit (V1, V2 and V3) following tests will be performed: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (fluorescein corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test -TBUT). The subjective evaluation of drug tolerability will be quantified by Visual Analog Scale (VAS). The evaluation of the association of quality of life and dry eye symptoms in respondents will be examined with the Ocular Surface Disease Index (OSDI) questionnaire.
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)
- Keywords
- glaucoma, ocular surface disease, preservative, treatment, Prostaglandin/timolol fixed combination, tolerability
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)Drug
Also called Fixalpost ( T2347), 50 micrograms/ml latanoprost + 5 mg/ml timolol maleate eye drops, solution in single-dose container
switching preserved prostaglandin analog- timolol FC (fixed combination) in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD) signs and symptoms to an equally effective and safe preservative - free (PF) latanoprost - timolol FC (Fixalpost).
form: preservative free latanoprost - timolol fix combination (50 micrograms/ml latanoprost + 5 mg/ml timolol), ocular solution dosage: once daily, at 8.00 p.m. duration: 3 months
| Study group | Role | What they receive |
|---|---|---|
| Switching the preserved to preservative free prostaglandin analog-timolol FC | Experimental | To switch preserved prostaglandin analog- timolol FC (Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container) in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD) signs and symptoms to an equally effective and safe preservative - free (PF) latanoprost - timolol FC in order to investigate whether that can result in alleviation or elimination of OSD and improvement of local tolerability. Receives: Drug: Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of drug tolerability
In this study, the following test is carried out at every visit (V1, V 2 and V3) every month to determine the change of drug tolerability:
The Visual Analog Scale is used to determine drug tolerability.
Measured: through study completion, an average of 6 months
Change of symptoms of ocular surface disease
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to determine the change of symptoms of ocular surface disease:
The subjects' symptoms of ocular surface disease is assessed using a standardized questionnaire - Ocular Surface Disease Index - OSDI questionnaire.
Measured: through study completion, an average of 6 months
Change of visual function
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to evaluate change of visual function:
Visual Acuity Testing (Snellen Chart).
Measured: through study completion, an average of 6 months
Change of signs of ocular surface disease
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to determine the change of symptoms of ocular surface disease:
Slit lamp examination (fluorescein staining of the cornea and conjunctiva, hyperemia of the conjunctiva)
Measured: through study completion, an average of 6 months
Change of tear film stability
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to evaluate change of signs of ocular surface disease:
assessment of the tear film stability by measuring the tear film break-up time (TBUT).
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Evaluation of the effectiveness of preservative-free latanoprost / timolol FC in terms of changing intraocular pressure values
In this study, applanation tonometry according to Goldmann will be performed at every visit (V1, V 2 and V3) every month to measure intraocular pressure in mmHg.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start8 Mar 2021
- Primary completion8 Sep 2021 (estimated)
- Study completion8 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Open-angle GlaucomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinički Bolnički Centar Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Responsible party
- Sponsor
- Investigators
- Sonja Jandroković, MD PhD, Principal investigator, Klinički Bolnički Centar Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891588
- Sponsor's protocol ID
- CR ZAG 02/21 AG 8.1-21/18-2
- Other IDs
- DRKS00024581
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xing Y, Zhu L, Zhang K, Huang S. The efficacy of the fixed combination of latanoprost and timolol versus other fixed combinations for primary open-angle glaucoma and ocular hypertension: A systematic review and meta-analysis. PLoS One. 2020 Feb 27;15(2):e0229682. doi: 10.1371/journal.pone.0229682. eCollection 2020.
PubMed 32106236Uusitalo H, Chen E, Pfeiffer N, Brignole-Baudouin F, Kaarniranta K, Leino M, Puska P, Palmgren E, Hamacher T, Hofmann G, Petzold G, Richter U, Riedel T, Winter M, Ropo A. Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication. Acta Ophthalmol. 2010 May;88(3):329-36. doi: 10.1111/j.1755-3768.2010.01907.x.
PubMed 20546237Misiuk-Hojlo M, Pomorska M, Mulak M, Rekas M, Wierzbowska J, Prost M, Wasyluk J, Lubinski W, Podboraczynska-Jodko K, Romaniuk W, Kinasz R, Ortyl-Markiewicz R, Mocko L, Zaleska-Zmijewska A, Rokicki D, Baudouin C. The RELIEF study: Tolerability and efficacy of preservative-free latanoprost in the treatment of glaucoma or ocular hypertension. Eur J Ophthalmol. 2019 Mar;29(2):210-215. doi: 10.1177/1120672118785280. Epub 2018 Jul 12.
PubMed 29998767Guven Yilmaz S, Degirmenci C, Karakoyun YE, Yusifov E, Ates H. The efficacy and safety of bimatoprost/timolol maleate, latanoprost/timolol maleate, and travoprost/timolol maleate fixed combinations on 24-h IOP. Int Ophthalmol. 2018 Aug;38(4):1425-1431. doi: 10.1007/s10792-017-0601-8. Epub 2017 Jun 14.
PubMed 28616797
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glaucoma or Ocular Hypertension Patients With Pre-existing Ocular Surface Disease Switched From a Preserved Prostaglandin Analog - Timolol Fixed Combination to a Preservative - Free Latanoprost - Timolol Fixed Combination
- ClinicalTrials.gov ID
- NCT04891588
- Acronym / sponsor ID
- CR ZAG 02/21 AG 8.1-21/18-2
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular surface disease, preservative, treatment, Prostaglandin/timolol fixed combination, tolerability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Klinički Bolnički Centar ZagrebUniversity, hospital or other
- Collaborators
- University of Zagreb
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Sep 2021 (estimated)
- Study completion
- 8 Dec 2021 (estimated)
- First posted
- 18 May 2021 (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.
Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic nerve damage and consequent visual loss. In most cases, it is associated with elevated intraocular pressure. If glaucoma left untreated, complete blindness can occur. Prostaglandin analog- timolol FCs are common glaucoma therapy because these drugs have been shown to effectively lower intraocular pressure (IOP). It is also known that chronic use of preservatives in the drops leads to ocular surface disease (OSD) which can lead to low tolerability of prescribed drops and gaps in the dosing regimen.
The purpose of this study is to investigate whether drug preservative elimination results in reduction of OSD symptoms and signs as well as improvement of latanoprost-timolol FC local tolerability in the treatment of glaucoma and ocular hypertension.
In this trial, on each visit (V1, V2 and V3) following tests will be used: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test - TBUT). Visual Analog Scale (VAS) will be used for a subjective assessment of drug tolerability. The association of quality of life and dry eye symptoms in participants will be measured by the Ocular Surface Disease Index (OSDI) questionnaire.
Detailed description
Glaucoma is a heterogeneous group of chronic ocular diseases characterized by a loss of the retinal nerve fiber layer and consequent damage to the optic nerve head. Increased intraocular pressure is considered a major risk factor for development of the disease. If glaucoma left untreated, visual field impairment and complete visual loss can occur. Due to the effective reduction of intraocular pressure, prostaglandin analog-timolol fixed combinations (FC) are considered to be a mainstay in glaucoma treatment. However, it is well known that long-term use of preservatives in glaucoma drops leads to ocular surface disease (OSD) which causes low tolerability and nonadherence with prescribed therapy.
The study is designed to determine whether switching from a preserved prostaglandin analog- timolol FC to an equally effective and safe preservative - free latanoprost - timolol FC can result in alleviation or elimination of OSD and improvement of local tolerability.
In this study, on each visit (V1, V2 and V3) following tests will be performed: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (fluorescein corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test -TBUT). The subjective evaluation of drug tolerability will be quantified by Visual Analog Scale (VAS). The evaluation of the association of quality of life and dry eye symptoms in respondents will be examined with the Ocular Surface Disease Index (OSDI) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switching the preserved to preservative free prostaglandin analog-timolol FC | Experimental | Drug: Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)To switch preserved prostaglandin analog- timolol FC (Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container) in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD) signs and symptoms to an equally effective and safe preservative - free (PF) latanoprost - timolol FC in order to investigate whether that can result in alleviation or elimination of OSD and improvement of local tolerability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with open angle galucoma or ocular hypertension that had been controlled (stable IOP <19mmHg) by commercially available preserved PGA -timolol FC for at least 3 months
- Stable visual field (based on at least two reliable visual field tests performed within the last 12 months)
- Central corneal thickness within the range 500-580µm.
- mild to moderate hyperaemia based on MacMonnies (scores 1 and 2)
Key exclusion criteria (6 listed)
- Best-corrected visual acuity (BCVA) 0,1 or lower
- Severe visual field defects (MD 12 dB or higher)
- Any intraocular surgery (other than filtration surgery performed at least 6 months before screening)
- Any ocular surface abnormality preventing accurate IOP measurement
- Acute ocular inflammation
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 |
|---|---|---|
| Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)Also: Fixalpost ( T2347), 50 micrograms/ml latanoprost + 5 mg/ml timolol maleate eye drops, solution in single-dose containerswitching preserved prostaglandin analog- timolol FC (fixed combination) in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD) signs and symptoms to an equally effective and safe preservative - free (PF) latanoprost - timolol FC (Fixalpost). form: preservative free latanoprost - timolol fix combination (50 micrograms/ml latanoprost + 5 mg/ml timolol), ocular solution dosage: once daily, at 8.00 p.m. duration: 3 months | Drug | Switching the preserved to preservative free prostaglandin analog-timolol FC |
Primary outcome
Change of drug tolerability
Time frame: through study completion, an average of 6 months
In this study, the following test is carried out at every visit (V1, V 2 and V3) every month to determine the change of drug tolerability: The Visual Analog Scale is used to determine drug tolerability.
Change of symptoms of ocular surface disease
Time frame: through study completion, an average of 6 months
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to determine the change of symptoms of ocular surface disease: The subjects' symptoms of ocular surface disease is assessed using a standardized questionnaire - Ocular Surface Disease Index - OSDI questionnaire.
Change of visual function
Time frame: through study completion, an average of 6 months
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to evaluate change of visual function: Visual Acuity Testing (Snellen Chart).
Change of signs of ocular surface disease
Time frame: through study completion, an average of 6 months
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to determine the change of symptoms of ocular surface disease: Slit lamp examination (fluorescein staining of the cornea and conjunctiva, hyperemia of the conjunctiva)
Change of tear film stability
Time frame: through study completion, an average of 6 months
In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to evaluate change of signs of ocular surface disease: assessment of the tear film stability by measuring the tear film break-up time (TBUT).
1 secondary outcome
Evaluation of the effectiveness of preservative-free latanoprost / timolol FC in terms of changing intraocular pressure values
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 32106236Xing Y, Zhu L, Zhang K, Huang S. The efficacy of the fixed combination of latanoprost and timolol versus other fixed combinations for primary open-angle glaucoma and ocular hypertension: A systematic review and meta-analysis. PLoS One. 2020 Feb 27;15(2):e0229682. doi: 10.1371/journal.pone.0229682. eCollection 2020.
- Background: PubMed 20546237Uusitalo H, Chen E, Pfeiffer N, Brignole-Baudouin F, Kaarniranta K, Leino M, Puska P, Palmgren E, Hamacher T, Hofmann G, Petzold G, Richter U, Riedel T, Winter M, Ropo A. Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication. Acta Ophthalmol. 2010 May;88(3):329-36. doi: 10.1111/j.1755-3768.2010.01907.x.
- Background: PubMed 29998767Misiuk-Hojlo M, Pomorska M, Mulak M, Rekas M, Wierzbowska J, Prost M, Wasyluk J, Lubinski W, Podboraczynska-Jodko K, Romaniuk W, Kinasz R, Ortyl-Markiewicz R, Mocko L, Zaleska-Zmijewska A, Rokicki D, Baudouin C. The RELIEF study: Tolerability and efficacy of preservative-free latanoprost in the treatment of glaucoma or ocular hypertension. Eur J Ophthalmol. 2019 Mar;29(2):210-215. doi: 10.1177/1120672118785280. Epub 2018 Jul 12.
- Background: PubMed 28616797Guven Yilmaz S, Degirmenci C, Karakoyun YE, Yusifov E, Ates H. The efficacy and safety of bimatoprost/timolol maleate, latanoprost/timolol maleate, and travoprost/timolol maleate fixed combinations on 24-h IOP. Int Ophthalmol. 2018 Aug;38(4):1425-1431. doi: 10.1007/s10792-017-0601-8. Epub 2017 Jun 14.
- Individual participant dataSharing planned: No
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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.
Sonja Jandroković, MD PhD principal investigator
Klinički Bolnički Centar Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC) in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonja Jandroković, MD PhD (+385 (01) 238 8430, sonja.jandrokovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of drug tolerability (time frame: through study completion, an average of 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891588, which also lists 4 linked publications.
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 18 May 2021.