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Completed

NCT Number: NCT03331770

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laboratoarios Poen

Buenos Aires, 1407, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Latanoprost Ophthalmic Product

Drug

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 names: Louten® Emulsion

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Laboratorios Poen

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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