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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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