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

NCT ID: NCT03331770

Last Updated: 2017-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2017-10-06

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.

Conditions

Primary Open-angle Glaucoma

Keywords

Benzalkonium Chloride; Latanoprost; BAK-free; Glaucoma; Ocular hypertension; conjunctival hyperemia; BUT; OSDI; Schirmer I; Corneal staining; Tear meniscus height

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Latanoprost Ophthalmic Product

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Louten® Emulsion

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Poen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejo Peyret, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Durand, Argentina

Javier Casiraghi, PhD

Role: STUDY_CHAIR

Hospital de Clínicas "Jose de San Martin"

Daniel Grigera, PhD

Role: STUDY_DIRECTOR

Hospital Santa Lucia

Locations

Laboratoarios Poen

Buenos Aires, , Argentina

Countries

Argentina

References

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.

Reference Type: BACKGROUND

PMID: 27274186 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28356710 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23881267 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27567675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24895141 (View on PubMed)

Other Identifiers

SOLEMU03

Identifier Type: -

Identifier Source: org_study_id