Primary Open-angle GlaucomaPhase 4NCT03331770
Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost
A Phase 4 study testing Latanoprost Ophthalmic Product in people with Primary Open-angle Glaucoma, run by Laboratorios Poen at 1 site in Argentina.
Trial summary
This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- Latanoprost Ophthalmic Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteArgentina
- Study dates
- 6 Jan 2017to 6 Oct 2017
- 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
- Men and women aged ≥ 18 years
- Diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma.
- Receiving containing-BAK latanoprost as monotherapy for at least 6 months
- Pachymetry between 520 and 580 microns
- Informed consent given
Who cannot join
- History of allergic hypersensitivity or poor tolerance to latanoprost or any components of the formula
- Angle closure glaucoma or secondary glaucoma
- History of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of surgery)
- History of cataract surgery during the last 6 months
- History of uveitis or intraocular inflammation
- Corneal alteration
- Pregnant patients, who wish to conceive or who are in the nursing period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Study to Evaluate the Efficacy and Tolerability of an Innovative Formulation of Benzalkonium Chloride-free Latanoprost in Patients With Primary Open-Angle Glaucoma
This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.
Read the detailed description
Latanoprost is a prostaglandin F2alfa analogue that increases the uveoscleral outflow of aqueous humor, resulting in a intraocular pressure (IOP) reduction. Benzalkonium chloride (BAK) is usually employed in formulations of prostaglandin analogues due to its dual action of preservative and adjuvant in the formulation. However, this preservative has known toxic effects on the ocular surface, causing ocular dryness and discomfort on long-term use. Benzalkonium Chloride-free (BAK-free)Latanoprost is a new formulation approved for the use in patients with primary open angle glaucoma /ocular hypertension. In this study, patients that were using BAK-containing latanoprost for ≥6 months, switched to a new formulation of BAK-free latanoprost ophthalmic emulsion to evaluate its hypotensive action and quantify the changes in ocular surface parameters.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- Latanoprost Ophthalmic Product
- Keywords
- Benzalkonium Chloride, Latanoprost, BAK-free, Glaucoma, Ocular hypertension, conjunctival hyperemia, BUT, OSDI, Schirmer I, Corneal staining, Tear meniscus height
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost Ophthalmic ProductDrug
Also called Louten® Emulsion
Multidose bottle, preserved with potassium sorbate, that can be stored at room temperature up to 30°C during all shelf life, the emulsion does not require shaking before use
| Study group | Role | What they receive |
|---|---|---|
| BAK-free latanoprost ophthalmic emulsion | Experimental | Patients with primary open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥ 6 months (baseline), switched to a new formulation of latanoprost ophthalmic product Receives: Drug: Latanoprost Ophthalmic Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Intraocular pressure
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Measured: After 4 weeks of treatment with BAK-free latanoprost
Intraocular pressure
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Measured: After 8 weeks of treatment with BAK-free latanoprost
Intraocular pressure
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Measured: After 12 weeks of treatment with BAK-free latanoprost
Secondary outcomes (24)
Ocular Surface Disease Index (OSDI)
The OSDI score is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and sever) and effect on vision related function. It is determined using OSDI questionnaire (score). The OSDI score is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal patients and patients with dry eye disease.
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Ocular Surface Disease Index (OSDI)
The OSDI score is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and sever) and effect on vision related function. It is determined using OSDI questionnaire (score). The OSDI score is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal patients and patients with dry eye disease.
Measured: After 4 weeks of treatment with BAK-free latanoprost
Ocular Surface Disease Index (OSDI)
The OSDI score is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and sever) and effect on vision related function. It is determined using OSDI questionnaire (score). The OSDI score is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal patients and patients with dry eye disease.
Measured: After 8 weeks of treatment with BAK-free latanoprost
Ocular Surface Disease Index (OSDI)
The OSDI score is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and sever) and effect on vision related function. It is determined using OSDI questionnaire (score). The OSDI score is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal patients and patients with dry eye disease.
Measured: After 12 weeks of treatment with BAK-free latanoprost
Conjunctival hyperemia
Patients on treatment with prostaglandin analogues preserved with BAK suffer from conjunctival hyperemia. It is the most common side effect that leads to discontinuation or non-compliance. It is determined with the slit lamp. It is classified as patients without hyperemia or with mild, moderate, or severe hyperemia.
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Conjunctival hyperemia
Patients on treatment with prostaglandin analogues preserved with BAK suffer from conjunctival hyperemia. It is the most common side effect that leads to discontinuation or non-compliance. It is determined with the slit lamp. It is classified as patients without hyperemia or with mild, moderate, or severe hyperemia.
Measured: After 4 weeks of treatment with BAK-free latanoprost
Conjunctival hyperemia
Patients on treatment with prostaglandin analogues preserved with BAK suffer from conjunctival hyperemia. It is the most common side effect that leads to discontinuation or non-compliance. It is determined with the slit lamp. It is classified as patients without hyperemia or with mild, moderate, or severe hyperemia.
Measured: After 8 weeks of treatment with BAK-free latanoprost
Conjunctival hyperemia
Patients on treatment with prostaglandin analogues preserved with BAK suffer from conjunctival hyperemia. It is the most common side effect that leads to discontinuation or non-compliance. It is determined with the slit lamp. It is classified as patients without hyperemia or with mild, moderate, or severe hyperemia.
Measured: After 12 weeks of treatment with BAK-free latanoprost
Schirmer I test
Schirmer test measures the production of tears. This test consists of placing a small strip of filter paper inside the lower eyelid (inferior fornix). The eyes are closed for 5 minutes. The paper is then removed and the amount of moisture is measured (millimeter).
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Schirmer I test
Schirmer test measures the production of tears. This test consists of placing a small strip of filter paper inside the lower eyelid (inferior fornix). The eyes are closed for 5 minutes. The paper is then removed and the amount of moisture is measured (millimeter).
Measured: After 4 weeks of treatment with BAK-free latanoprost
Schirmer I test
Schirmer test measures the production of tears. This test consists of placing a small strip of filter paper inside the lower eyelid (inferior fornix). The eyes are closed for 5 minutes. The paper is then removed and the amount of moisture is measured (millimeter).
Measured: After 8 weeks of treatment with BAK-free latanoprost
Schirmer I test
Schirmer test measures the production of tears. This test consists of placing a small strip of filter paper inside the lower eyelid (inferior fornix). The eyes are closed for 5 minutes. The paper is then removed and the amount of moisture is measured (millimeter).
Measured: After 12 weeks of treatment with BAK-free latanoprost
Break up time (BUT)
Tear film break-up time (TBUT) is a method for determining the stability of the tear film and checking evaporative dry eye. In testing for TBUT, sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop. The BUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film.
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Break up time (BUT)
Tear film break-up time (TBUT) is a method for determining the stability of the tear film and checking evaporative dry eye. In testing for TBUT, sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop. The BUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film.
Measured: After 4 weeks of treatment with BAK-free latanoprost
Break up time (BUT)
Tear film break-up time (TBUT) is a method for determining the stability of the tear film and checking evaporative dry eye. In testing for TBUT, sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop. The BUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film.
Measured: After 8 weeks of treatment with BAK-free latanoprost
Break up time (BUT)
Tear film break-up time (TBUT) is a method for determining the stability of the tear film and checking evaporative dry eye. In testing for TBUT, sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop. The BUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film.
Measured: After 12 weeks of treatment with BAK-free latanoprost
Corneal epithelial fluorescein staining
This is a test that uses orange dye (fluorescein) and a blue light to detect damage to the cornea. Fluorescein does not stain intact corneal epithelium but does stain corneal stroma, thus demarcating the area of the epithelial loss. Number of patients with corneal epithelial defects classified as inferior punctata keratitis or central corneal keratitis.
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Corneal epithelial fluorescein staining
This is a test that uses orange dye (fluorescein) and a blue light to detect damage to the cornea. Fluorescein does not stain intact corneal epithelium but does stain corneal stroma, thus demarcating the area of the epithelial loss. Number of patients with corneal epithelial defects classified as inferior punctata keratitis or central corneal keratitis.
Measured: After 4 weeks of treatment with BAK-free latanoprost
Corneal epithelial fluorescein staining
This is a test that uses orange dye (fluorescein) and a blue light to detect damage to the cornea. Fluorescein does not stain intact corneal epithelium but does stain corneal stroma, thus demarcating the area of the epithelial loss. Number of patients with corneal epithelial defects classified as inferior punctata keratitis or central corneal keratitis.
Measured: After 8 weeks of treatment with BAK-free latanoprost
Corneal epithelial fluorescein staining
This is a test that uses orange dye (fluorescein) and a blue light to detect damage to the cornea. Fluorescein does not stain intact corneal epithelium but does stain corneal stroma, thus demarcating the area of the epithelial loss. Number of patients with corneal epithelial defects classified as inferior punctata keratitis or central corneal keratitis.
Measured: After 12 weeks of treatment with BAK-free latanoprost
Tear meniscus height
The height of the tear meniscus is related to the tear secretion rate and tear stability, and it is a good indicator of the overall tear volume. It is measured with a slit lamp and classified as normal, increased or decreased (millimeter).
Measured: At the baseline (still on treatment with BAK-containing latanoprost)
Tear meniscus height
The height of the tear meniscus is related to the tear secretion rate and tear stability, and it is a good indicator of the overall tear volume. It is measured with a slit lamp and classified as normal, increased or decreased (millimeter).
Measured: After 4 weeks of treatment with BAK-free latanoprost
Tear meniscus height
The height of the tear meniscus is related to the tear secretion rate and tear stability, and it is a good indicator of the overall tear volume. It is measured with a slit lamp and classified as normal, increased or decreased (millimeter).
Measured: After 8 weeks of treatment with BAK-free latanoprost
Tear meniscus height
The height of the tear meniscus is related to the tear secretion rate and tear stability, and it is a good indicator of the overall tear volume. It is measured with a slit lamp and classified as normal, increased or decreased (millimeter).
Measured: After 12 weeks of treatment with BAK-free latanoprost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start6 Jan 2017
- Primary completion6 Oct 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, open-label, single-arm, multicenter, 12-week study
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Poen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejo Peyret, PhD, Principal investigator, Hospital Durand, ArgentinaJavier Casiraghi, PhD, Study chair, Hospital de Clínicas "Jose de San Martin"Daniel Grigera, PhD, Study director, Hospital Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331770
- Sponsor's protocol ID
- SOLEMU03
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Walimbe T, Chelerkar V, Bhagat P, Joshi A, Raut A. Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma. Clin Ophthalmol. 2016 May 9;10:821-7. doi: 10.2147/OPTH.S102976. eCollection 2016.
PubMed 27274186Munoz Negrete FJ, Lemij HG, Erb C. Switching to preservative-free latanoprost: impact on tolerability and patient satisfaction. Clin Ophthalmol. 2017 Mar 21;11:557-566. doi: 10.2147/OPTH.S126042. eCollection 2017.
PubMed 28356710Cucherat M, Stalmans I, Rouland JF. Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension: an adjusted Indirect comparison meta-analysis of randomized clinical trials. J Glaucoma. 2014 Jan;23(1):e69-75. doi: 10.1097/IJG.0b013e3182a075e6.
PubMed 23881267Denis P; Monoprost French Study Group. [Unpreserved latanoprost in the treatment of open-angle glaucoma and ocular hypertension. A multicenter, randomized, controlled study]. J Fr Ophtalmol. 2016 Sep;39(7):622-30. doi: 10.1016/j.jfo.2016.05.006. Epub 2016 Aug 25. French.
PubMed 27567675Sanford M. Preservative-free latanoprost eye drops in patients with primary open-angle glaucoma/ocular hypertension. Clin Drug Investig. 2014 Jul;34(7):521-8. doi: 10.1007/s40261-014-0203-4.
PubMed 24895141
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study to Evaluate the Efficacy and Tolerability of an Innovative Formulation of Benzalkonium Chloride-free Latanoprost in Patients With Primary Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT03331770
- Acronym / sponsor ID
- SOLEMU03
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Benzalkonium Chloride, Latanoprost, BAK-free, Glaucoma, Ocular hypertension, conjunctival hyperemia, BUT, OSDI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Laboratorios PoenIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 6 Nov 2017 (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.
This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.
Detailed description
Latanoprost is a prostaglandin F2alfa analogue that increases the uveoscleral outflow of aqueous humor, resulting in a intraocular pressure (IOP) reduction. Benzalkonium chloride (BAK) is usually employed in formulations of prostaglandin analogues due to its dual action of preservative and adjuvant in the formulation. However, this preservative has known toxic effects on the ocular surface, causing ocular dryness and discomfort on long-term use. Benzalkonium Chloride-free (BAK-free)Latanoprost is a new formulation approved for the use in patients with primary open angle glaucoma /ocular hypertension. In this study, patients that were using BAK-containing latanoprost for ≥6 months, switched to a new formulation of BAK-free latanoprost ophthalmic emulsion to evaluate its hypotensive action and quantify the changes in ocular surface parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, open-label, single-arm, multicenter, 12-week study
| Arm | Type | Receives |
|---|---|---|
| BAK-free latanoprost ophthalmic emulsion | Experimental | Drug: Latanoprost Ophthalmic ProductPatients with primary open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥ 6 months (baseline), switched to a new formulation of latanoprost ophthalmic product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged ≥ 18 years
- Diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma.
- Receiving containing-BAK latanoprost as monotherapy for at least 6 months
- Pachymetry between 520 and 580 microns
- Informed consent given
Key exclusion criteria (7 listed)
- History of allergic hypersensitivity or poor tolerance to latanoprost or any components of the formula
- Angle closure glaucoma or secondary glaucoma
- History of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of surgery)
- History of cataract surgery during the last 6 months
- History of uveitis or intraocular 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 |
|---|---|---|
| Latanoprost Ophthalmic ProductAlso: Louten® EmulsionMultidose bottle, preserved with potassium sorbate, that can be stored at room temperature up to 30°C during all shelf life, the emulsion does not require shaking before use | Drug | BAK-free latanoprost ophthalmic emulsion |
Primary outcome
Intraocular pressure
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Intraocular pressure
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Intraocular pressure
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
Intraocular pressure
Time frame: After 12 weeks of treatment with BAK-free latanoprost
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg).
24 secondary outcomes
Ocular Surface Disease Index (OSDI)
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Ocular Surface Disease Index (OSDI)
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Ocular Surface Disease Index (OSDI)
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Ocular Surface Disease Index (OSDI)
Time frame: After 12 weeks of treatment with BAK-free latanoprost
Conjunctival hyperemia
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Conjunctival hyperemia
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Conjunctival hyperemia
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Conjunctival hyperemia
Time frame: After 12 weeks of treatment with BAK-free latanoprost
Schirmer I test
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Schirmer I test
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Schirmer I test
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Schirmer I test
Time frame: After 12 weeks of treatment with BAK-free latanoprost
Break up time (BUT)
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Break up time (BUT)
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Break up time (BUT)
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Break up time (BUT)
Time frame: After 12 weeks of treatment with BAK-free latanoprost
Corneal epithelial fluorescein staining
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Corneal epithelial fluorescein staining
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Corneal epithelial fluorescein staining
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Corneal epithelial fluorescein staining
Time frame: After 12 weeks of treatment with BAK-free latanoprost
Tear meniscus height
Time frame: At the baseline (still on treatment with BAK-containing latanoprost)
Tear meniscus height
Time frame: After 4 weeks of treatment with BAK-free latanoprost
Tear meniscus height
Time frame: After 8 weeks of treatment with BAK-free latanoprost
Tear meniscus height
Time frame: After 12 weeks of treatment with BAK-free latanoprost
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 8 Nov 2017.
- Background: PubMed 27274186Walimbe T, Chelerkar V, Bhagat P, Joshi A, Raut A. Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma. Clin Ophthalmol. 2016 May 9;10:821-7. doi: 10.2147/OPTH.S102976. eCollection 2016.
- Background: PubMed 28356710Munoz Negrete FJ, Lemij HG, Erb C. Switching to preservative-free latanoprost: impact on tolerability and patient satisfaction. Clin Ophthalmol. 2017 Mar 21;11:557-566. doi: 10.2147/OPTH.S126042. eCollection 2017.
- Background: PubMed 23881267Cucherat M, Stalmans I, Rouland JF. Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension: an adjusted Indirect comparison meta-analysis of randomized clinical trials. J Glaucoma. 2014 Jan;23(1):e69-75. doi: 10.1097/IJG.0b013e3182a075e6.
- Background: PubMed 27567675Denis P; Monoprost French Study Group. [Unpreserved latanoprost in the treatment of open-angle glaucoma and ocular hypertension. A multicenter, randomized, controlled study]. J Fr Ophtalmol. 2016 Sep;39(7):622-30. doi: 10.1016/j.jfo.2016.05.006. Epub 2016 Aug 25. French.
- Background: PubMed 24895141Sanford M. Preservative-free latanoprost eye drops in patients with primary open-angle glaucoma/ocular hypertension. Clin Drug Investig. 2014 Jul;34(7):521-8. doi: 10.1007/s40261-014-0203-4.
- 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.
Alejo Peyret, PhD principal investigator
Hospital Durand, Argentina
Javier Casiraghi, PhD study chair
Hospital de Clínicas "Jose de San Martin"
Daniel Grigera, PhD study director
Hospital Santa Lucia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latanoprost Ophthalmic Product in people with Primary Open-angle Glaucoma, run by Laboratorios Poen at 1 site 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 5 inclusion and 7 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 8 Nov 2017. 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 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?
Intraocular pressure (time frame: At the baseline (still on treatment with BAK-containing latanoprost)). The study lists 4 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 NCT03331770, which also lists 5 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 8 Nov 2017.