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Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost

Primary Purpose

Primary Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Latanoprost Ophthalmic Product
Sponsored by
Laboratorios Poen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Benzalkonium Chloride, Latanoprost, BAK-free, Glaucoma, Ocular hypertension, conjunctival hyperemia, BUT, OSDI, Schirmer I, Corneal staining, Tear meniscus height

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Laboratoarios Poen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BAK-free latanoprost ophthalmic emulsion

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).

Full Information

First Posted
October 25, 2017
Last Updated
November 6, 2017
Sponsor
Laboratorios Poen
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1. Study Identification

Unique Protocol Identification Number
NCT03331770
Brief Title
Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 6, 2017 (Actual)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
October 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Poen

4. Oversight

Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
Benzalkonium Chloride, Latanoprost, BAK-free, Glaucoma, Ocular hypertension, conjunctival hyperemia, BUT, OSDI, Schirmer I, Corneal staining, Tear meniscus height

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
A prospective, open-label, single-arm, multicenter, 12-week study
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAK-free latanoprost ophthalmic emulsion
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Latanoprost Ophthalmic Product
Other Intervention Name(s)
Louten® Emulsion
Intervention Description
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
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
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).
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Intraocular pressure
Description
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).
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Intraocular pressure
Description
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).
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Intraocular pressure
Description
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).
Time Frame
After 12 weeks of treatment with BAK-free latanoprost
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
After 12 weeks of treatment with BAK-free latanoprost
Title
Conjunctival hyperemia
Description
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.
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Conjunctival hyperemia
Description
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.
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Conjunctival hyperemia
Description
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.
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Conjunctival hyperemia
Description
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.
Time Frame
After 12 weeks of treatment with BAK-free latanoprost
Title
Schirmer I test
Description
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).
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Schirmer I test
Description
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).
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Schirmer I test
Description
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).
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Schirmer I test
Description
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).
Time Frame
After 12 weeks of treatment with BAK-free latanoprost
Title
Break up time (BUT)
Description
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.
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Break up time (BUT)
Description
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.
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Break up time (BUT)
Description
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.
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Break up time (BUT)
Description
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.
Time Frame
After 12 weeks of treatment with BAK-free latanoprost
Title
Corneal epithelial fluorescein staining
Description
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.
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Corneal epithelial fluorescein staining
Description
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.
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Corneal epithelial fluorescein staining
Description
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.
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Corneal epithelial fluorescein staining
Description
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.
Time Frame
After 12 weeks of treatment with BAK-free latanoprost
Title
Tear meniscus height
Description
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).
Time Frame
At the baseline (still on treatment with BAK-containing latanoprost)
Title
Tear meniscus height
Description
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).
Time Frame
After 4 weeks of treatment with BAK-free latanoprost
Title
Tear meniscus height
Description
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).
Time Frame
After 8 weeks of treatment with BAK-free latanoprost
Title
Tear meniscus height
Description
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).
Time Frame
After 12 weeks of treatment with BAK-free latanoprost

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejo Peyret, PhD
Organizational Affiliation
Hospital Durand, Argentina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Casiraghi, PhD
Organizational Affiliation
Hospital de Clínicas "Jose de San Martin"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel Grigera, PhD
Organizational Affiliation
Hospital Santa Lucia
Official's Role
Study Director
Facility Information:
Facility Name
Laboratoarios Poen
City
Buenos Aires
ZIP/Postal Code
1407
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27274186
Citation
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.
Results Reference
background
PubMed Identifier
28356710
Citation
Munoz 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. Erratum In: Clin Ophthalmol. 2017 May 11;11:887.
Results Reference
background
PubMed Identifier
23881267
Citation
Cucherat 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.
Results Reference
background
PubMed Identifier
27567675
Citation
Denis 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.
Results Reference
background
PubMed Identifier
24895141
Citation
Sanford 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.
Results Reference
background

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Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost

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