Clinical trial NCT03331770: 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
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Laboratorios Poen
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, open-label, single-arm, multicenter, 12-week study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intraocular pressure
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Intraocular pressure
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Intraocular pressure
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Intraocular pressure
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Ocular Surface Disease Index (OSDI)
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Ocular Surface Disease Index (OSDI)
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Ocular Surface Disease Index (OSDI)
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
measure: Conjunctival hyperemia
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Conjunctival hyperemia
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Conjunctival hyperemia
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Conjunctival hyperemia
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
measure: Schirmer I test
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Schirmer I test
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Schirmer I test
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Schirmer I test
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
measure: Break up time (BUT)
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Break up time (BUT)
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Break up time (BUT)
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Break up time (BUT)
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
measure: Corneal epithelial fluorescein staining
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Corneal epithelial fluorescein staining
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Corneal epithelial fluorescein staining
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Corneal epithelial fluorescein staining
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
measure: Tear meniscus height
timeFrame: At the baseline (still on treatment with BAK-containing latanoprost)
measure: Tear meniscus height
timeFrame: After 4 weeks of treatment with BAK-free latanoprost
measure: Tear meniscus height
timeFrame: After 8 weeks of treatment with BAK-free latanoprost
measure: Tear meniscus height
timeFrame: After 12 weeks of treatment with BAK-free latanoprost
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Laboratoarios Poen
Study officials:
affiliation: Hospital Durand, Argentina
name: Alejo Peyret, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas "Jose de San Martin"
name: Javier Casiraghi, PhD
role: STUDY_CHAIR
affiliation: Hospital Santa Lucia
name: Daniel Grigera, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.