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

NCT03331770 | Completed Phase 4

• 1 other identifier: SOLEMU03
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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).

  At the baseline (still on treatment with BAK-containing latanoprost)

• 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).

  After 4 weeks of treatment with BAK-free latanoprost

• 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).

  After 8 weeks of treatment with BAK-free latanoprost

• 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).

  After 12 weeks of treatment with BAK-free latanoprost

Secondary Outcomes (24)

• Ocular Surface Disease Index (OSDI)

  At the baseline (still on treatment with BAK-containing latanoprost)

• Ocular Surface Disease Index (OSDI)

  After 4 weeks of treatment with BAK-free latanoprost

• Ocular Surface Disease Index (OSDI)

  After 8 weeks of treatment with BAK-free latanoprost

• Ocular Surface Disease Index (OSDI)

  After 12 weeks of treatment with BAK-free latanoprost

• Conjunctival hyperemia

  At the baseline (still on treatment with BAK-containing latanoprost)

Study Arms (1)

BAK-free latanoprost ophthalmic emulsion

EXPERIMENTAL

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

Interventions

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

Also known as: Louten® Emulsion

BAK-free latanoprost ophthalmic emulsion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Poen: lead

Study Sites (1)

Laboratoarios Poen

Buenos Aires, 1407, Argentina

Location

Related Publications (5)

• 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.

  PMID: 27274186 BACKGROUND

• 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.

  PMID: 28356710 BACKGROUND

• 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.

  PMID: 23881267 BACKGROUND

• 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.

  PMID: 27567675 BACKGROUND

• 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.

  PMID: 24895141 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Alejo Peyret, PhD

  Hospital Durand, Argentina

  PRINCIPAL INVESTIGATOR

• Javier Casiraghi, PhD

  Hospital de Clínicas "Jose de San Martin"

  STUDY CHAIR

• Daniel Grigera, PhD

  Hospital Santa Lucia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, open-label, single-arm, multicenter, 12-week study

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 6, 2017
• Study Start: January 6, 2017
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)