CompletedPhase 4

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

Argentina103 participantsStarted 2017-01-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Intraocular pressure

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

Intraocular pressure

Timeframe: After 4 weeks of treatment with BAK-free latanoprost

Intraocular pressure

Timeframe: After 8 weeks of treatment with BAK-free latanoprost

Intraocular pressure

Timeframe: After 12 weeks of treatment with BAK-free latanoprost

Trial details

NCT IDNCT03331770

SponsorLaboratorios Poen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-06

View on ClinicalTrials.gov More Primary Open-angle Glaucoma trials