Comparing preservative-free and preserved glaucoma eye drops, with chatbot follow-up — one of only 35 trials in 803 that carry a phase (Tecnoquimicas, NCT07690397)
A Phase 4 trial in patients with primary open-angle glaucoma or ocular hypertension comparing a preservative-free dorzolamide-timolol-brimonidine combination against one containing preservatives. The primary aim is ocular surface safety, with adherence, therapeutic efficacy and biomolecular markers also compared. Chatbot follow-up appears in the title.
Trial overview (primary data)
- StatusActive, not recruiting
- ConditionsPrimary Open-Angle Glaucoma (POAG), Ocular Hypertension
- InterventionsCOMBINATION_PRODUCT: Preservative-free dorzolamide-timolol-brimonidine combination, COMBINATION_PRODUCT: Preservative dorzolamide-timolol-brimonidine combination
- SponsorTecnoquimicas
- Target enrollment140 participants
- Period2026-06-10 〜 2027-09-01
Key points
- A Phase 4 trial comparing preservative-free and preserved dorzolamide-timolol-brimonidine combination eye drops.
- The primary aim is ocular surface safety rather than how far intraocular pressure falls; adherence, efficacy and biomolecular markers are also compared.
- The record notes preservatives prevent bacterial contamination and that new bottle technology allows solutions without them.
- Chatbot follow-up appears in the title of the study. Planned enrollment is 140.
- Of the 803 trials this site holds as of 2026-08-31, 35 carry a phase (13 Phase 4, 11 Phase 2, 7 Phase 3, 4 Phase 1); the remaining 768 are not applicable or blank.
- The main objective is what happens to the ocular surface rather than how far pressure falls, with adherence also compared.
1Preservatives, a question apart from efficacy
Eye drops have carried preservatives to prevent bacterial contamination after opening. Glaucoma drops, though, are used every day and for years. The same substance touching the ocular surface over and over can accumulate burden as dryness or irritation. What this trial places as its primary aim is not how far intraocular pressure falls but what happens to the surface of the eye. For a medicine whose efficacy is already established, it asks whether it can be kept up.
2It does not work if it is not continued
That adherence sits among the comparisons says much about the design. Glaucoma drops hold pressure down by being used at set times. Where the eye is uncomfortable, the number of applications naturally falls. Efficacy and being able to continue are separate variables, and if the second gives way the first never materializes in practice.
That a trial comparing preservatives measures both ocular surface condition and adherence follows from that, and chatbot follow-up reads as a means of tracking whether use is continuing.
3Only 35 of 803 trials carry a phase
Classifying the 803 medical-AI clinical trials this site holds as of 2026-08-31 by phase gives 13 in Phase 4, 11 in Phase 2, 7 in Phase 3 and 4 in Phase 1 — 35 in total. The remaining 768 are marked not applicable or carry no entry. Drug trials proceed through Phase 1 to Phase 4, but most AI trials do not fit that frame, because evaluating software or a device differs in nature from raising a dose while watching safety.
This trial is Phase 4 because its subject is a comparison of approved medicines rather than AI itself, with AI built in as the means of follow-up.
4Whether it works, and whether it can be continued
What this trial places as its main objective is not how far intraocular pressure falls. For a drug whose efficacy is already established, it asks whether it can be continued.
Glaucoma drops are used daily, for years. The same agent touching the ocular surface repeatedly can accumulate burden in the form of dryness and irritation. Where the eye is uncomfortable, the number of instillations naturally falls, and the drug effect does not materialise. Using a chatbot for follow-up reads as a means of knowing whether use is continuing.
Why it matters
Counting medical-AI trials, few fall inside the phase framework. A classification premised on stages of drug development does not fit evaluation of software or devices. Trials like this one, where AI is not the subject but the means of follow-up, also show that what counts as an AI trial changes the tally.
FAQ
Why do preservatives matter?
Why measure adherence too?
Why is it Phase 4?
Sources (primary)
Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT07690397