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

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ClinicalTrials.gov Identifier: NCT03331770
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratorios Poen

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.

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Drug: Latanoprost Ophthalmic Product Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective, open-label, single-arm, multicenter, 12-week study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : October 6, 2017
Actual Study Completion Date : October 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: BAK-free latanoprost ophthalmic emulsion
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
Drug: Latanoprost Ophthalmic Product
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
Other Name: Louten® Emulsion




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).


Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: At the baseline (still on treatment with BAK-containing latanoprost) ]
    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.

  2. Ocular Surface Disease Index (OSDI) [ Time Frame: After 4 weeks of treatment with BAK-free latanoprost ]
    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.

  3. Ocular Surface Disease Index (OSDI) [ Time Frame: After 8 weeks of treatment with BAK-free latanoprost ]
    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.

  4. Ocular Surface Disease Index (OSDI) [ Time Frame: After 12 weeks of treatment with BAK-free latanoprost ]
    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.

  5. Conjunctival hyperemia [ Time Frame: At the baseline (still on treatment with BAK-containing latanoprost) ]
    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.

  6. Conjunctival hyperemia [ Time Frame: After 4 weeks of treatment with BAK-free latanoprost ]
    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.

  7. Conjunctival hyperemia [ Time Frame: After 8 weeks of treatment with BAK-free latanoprost ]
    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.

  8. Conjunctival hyperemia [ Time Frame: After 12 weeks of treatment with BAK-free latanoprost ]
    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.

  9. Schirmer I test [ Time Frame: At the baseline (still on treatment with BAK-containing latanoprost) ]
    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).

  10. Schirmer I test [ Time Frame: After 4 weeks of treatment with BAK-free latanoprost ]
    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).

  11. Schirmer I test [ Time Frame: After 8 weeks of treatment with BAK-free latanoprost ]
    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).

  12. Schirmer I test [ Time Frame: After 12 weeks of treatment with BAK-free latanoprost ]
    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).

  13. Break up time (BUT) [ Time Frame: At the baseline (still on treatment with BAK-containing latanoprost) ]
    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.

  14. Break up time (BUT) [ Time Frame: After 4 weeks of treatment with BAK-free latanoprost ]
    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.

  15. Break up time (BUT) [ Time Frame: After 8 weeks of treatment with BAK-free latanoprost ]
    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.

  16. Break up time (BUT) [ Time Frame: After 12 weeks of treatment with BAK-free latanoprost ]
    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.

  17. Corneal epithelial fluorescein staining [ Time Frame: At the baseline (still on treatment with BAK-containing latanoprost) ]
    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.

  18. Corneal epithelial fluorescein staining [ Time Frame: After 4 weeks of treatment with BAK-free latanoprost ]
    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.

  19. Corneal epithelial fluorescein staining [ Time Frame: After 8 weeks of treatment with BAK-free latanoprost ]
    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.

  20. Corneal epithelial fluorescein staining [ Time Frame: After 12 weeks of treatment with BAK-free latanoprost ]
    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.

  21. Tear meniscus height [ Time Frame: At the baseline (still on treatment with BAK-containing latanoprost) ]
    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).

  22. Tear meniscus height [ Time Frame: After 4 weeks of treatment with BAK-free latanoprost ]
    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).

  23. Tear meniscus height [ Time Frame: After 8 weeks of treatment with BAK-free latanoprost ]
    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).

  24. Tear meniscus height [ Time Frame: After 12 weeks of treatment with BAK-free latanoprost ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331770


Locations
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Argentina
Laboratoarios Poen
Buenos Aires, Argentina, 1407
Sponsors and Collaborators
Laboratorios Poen
Investigators
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Principal Investigator: Alejo Peyret, PhD Hospital Durand, Argentina
Study Chair: Javier Casiraghi, PhD Hospital de Clínicas "Jose de San Martin"
Study Director: Daniel Grigera, PhD Hospital Santa Lucia

Publications:
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Responsible Party: Laboratorios Poen
ClinicalTrials.gov Identifier: NCT03331770     History of Changes
Other Study ID Numbers: SOLEMU03
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: No
Keywords provided by Laboratorios Poen:
Benzalkonium Chloride
Latanoprost
BAK-free
Glaucoma
Ocular hypertension
conjunctival hyperemia
BUT
OSDI
Schirmer I
Corneal staining
Tear meniscus height
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Benzalkonium Compounds
Latanoprost
Antihypertensive Agents
Anti-Infective Agents, Local
Anti-Infective Agents