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Could removing preservatives from glaucoma drops save Patients' eyes?

NCT ID NCT07690397

Disease control Sponsor: Tecnoquimicas Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study compares two versions of a three-drug combination eye drop for glaucoma: one with preservatives and one without. Researchers want to see if the preservative-free version is gentler on the eye surface and leads to better treatment adherence. Participants will also use a chatbot for follow-up, and the study will measure changes in eye health, quality of life, and biomarkers in tears over four months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
preservative-free dorzolamide-timolol-brimonidine combination eye drops
What this could lead to
If successful, this could show that preservative-free eye drops are gentler on the eye surface and improve how consistently patients take their glaucoma medication.
What could go wrong
This is a mid-stage study with 140 participants, so results may not apply to all glaucoma patients. The chatbot follow-up is a new approach that may not improve adherence as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age 18 years or older. * Diagnosis of primary open-angle glaucoma or ocular hypertension, confirmed by the treating ophthalmologist. * Continuous and stable treatment with a topical fixed-dose combination of dorzolamide, timolol, and brimonidine in a preservative formulation, for a minimum of 3 months and a maximum of 12 months prior to study enrollment. * No prior use of preservative-free formulations of dorzolamide, timolol, and brimonidine. * Exclusive use of the fixed-dose combination of dorzolamide, timolol, and brimonidine, without other concomitant ocular hypotensive agents. * Ability to attend all study visits and procedures. * Signed written informed consent. Exclusion Criteria: Patients with any of the following conditions will be excluded: * History of glaucoma, retinal, or cataract surgery. * History of corneal refractive surgery (LASIK, PRK, SMILE). * Diagnosis of secondary glaucoma (neovascular, inflammatory, traumatic, or other secondary causes). * History of previous iridotomy, iridoplasty, or trabeculoplasty procedures. * Presence of concomitant ocular diseases that may interfere with the evaluation of the ocular surface (e.g., Sjögren's syndrome, active infectious keratitis, or severe ocular allergy). * Decompensated systemic conditions that contraindicate the use of topical beta-blockers (uncontrolled asthma, bradycardia, second- or third-degree AV block). * Pregnancy or breastfeeding. * Any medical or ophthalmological condition that, in the investigator's judgment, compromises the participant's safety or the validity of the data.

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Conditions

The condition(s) this trial relates to.

ocular hypertension open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular hypertension Primary open angle glaucoma (POAG)

Contacts and locations

Locations

  • Clínica Sigma Cali

    Cali, Valle del Cauca Department, 760044, Colombia

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