Primary Open-Angle Glaucoma (POAG)Phase 4GLAUCO-TECHNCT07690397

Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH

A Phase 4 study testing Preservative-free dorzolamide-timolol-brimonidine combination and Preservative dorzolamide-timolol-brimonidine combination in people with Primary Open-Angle Glaucoma (POAG) and Ocular Hypertension, run by Tecnoquimicas at 1 site in Colombia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The primary objective of this study is to evaluate the ocular surface safety of an ophthalmic solution indicated for the management of glaucoma, containing the active ingredients dorzolamide, timolol, and brimonidine, in patients diagnosed with primary open-angle glaucoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open-Angle Glaucoma (POAG), Ocular Hypertension
What is being tested?: Preservative-free dorzolamide-timolol-brimonidine combination and Preservative dorzolamide-timolol-brimonidine combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteColombia
Study dates: 10 Jun 2026to 1 Sep 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 15Show fewer

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Clínica Sigma Cali
Cali, Valle del Cauca Department, 760044

Other trials in Colombia

About this study

Official title: GLAUCO-TECH Study: Safety & Efficacy of Preservative-free vs. Preserved Dorzolamide-Timolol-Brimonidine. Impact on the Ocular Surface, Glaucoma Progression, Tear Proteomics, and AI/Chatbot-led Patient Follow-up.

In patients with ocular hypertension or open-angle glaucoma, does treatment with the preservative-free dorzolamide-timolol-brimonidine combination improve ocular surface health?

Will there be differences in treatment adherence between patients with ocular hypertension or open-angle glaucoma using a preservative-free dorzolamide-timolol-brimonidine combination versus a combination with preservatives?

Will there be differences in therapeutic efficacy between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination?

Will there be differences in changes in biomolecular markers on the ocular surface between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination?

Researchers will study these differences by comparing a formulation with the dorzolamide, timolol, and brimonidine combination that uses a preservative versus another with the same combination that does not use preservatives. Preservatives are used in ophthalmic solutions to prevent bacterial contamination. New technological developments in bottles allow for solutions without the need for preservatives. Participants must:

Take their medication according to the investigator's instructions for at least 4 months
Attend follow-up appointments at the beginning, and every 2 months until 4 months have passed
Answer phone calls every 15 days
Complete the quality of life questionnaires within the timeframes defined by the investigator

Read the detailed description

A prospective, randomized, comparative, single-blind (masked evaluator) clinical trial will evaluate the preservative-free fixed-dose combination of dorzolamide, timolol, and brimonidine versus the same combination with preservatives in patients diagnosed with primary open-angle glaucoma or ocular hypertension treated in Cali, Colombia.

Adult patients with a clinical indication for topical triple hypotensive therapy, currently receiving treatment with the preservative formulation or in the process of initiating or changing treatment, will be included. Participants will be assigned to one of the two treatment groups and will be followed longitudinally under real-world clinical practice conditions, with standardized measurements.

The primary objective of the study is to compare the impact of both formulations on ocular surface health, integrating objective and subjective measures of dry eye. Secondary objectives include evaluating intraocular pressure control, ocular and systemic safety and tolerability, treatment adherence, vision-related quality of life, and signs of structural and functional glaucomatous progression. In addition, the study incorporates two substudies. The technology substudy will evaluate the effect of an educational chatbot and reminders on patient adherence, disease knowledge, and self-efficacy. The molecular substudy will explore the proteomic profile of the tear film and its variation in response to treatment, in order to identify molecular markers associated with tolerability, ocular surface inflammation, and clinical response.

Conditions: Primary Open-Angle Glaucoma (POAG), Ocular Hypertension
Being tested: Preservative-free dorzolamide-timolol-brimonidine combination, Preservative dorzolamide-timolol-brimonidine combination
Keywords: GLAUCO-TECH, glaucoma therapy, molecular evaluation
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preservative-free dorzolamide-timolol-brimonidine combinationCombination product
Also called Biomarkers, OSDI, Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record
At the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests. During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence. Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.
Preservative dorzolamide-timolol-brimonidine combinationCombination product
Also called Biomarkers, OSDI, Educational Chatbot and Artificial Intelligence-Assisted Electronic Health Record
At the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests. During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence. Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.

Study groups in NCT07690397
Study group	Role	What they receive
Preservative-free dorzolamide-timolol-brimonidine combination	Active comparator	Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months. Receives: Combination Product: Preservative dorzolamide-timolol-brimonidine combination
Preservative dorzolamide-timolol-brimonidine combination	Other	Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months. Receives: Combination Product: Preservative-free dorzolamide-timolol-brimonidine combination

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in efficacy and quality of life and adherence questionnaires between two different formulations
Are there significant differences in ocular surface health, adherence, quality of life, or clinical effectiveness between patients treated with preservative-free Dorzolamide-Timolol-Brimonidine and those receiving preservative-containing Dorzolamide-Timolol-Brimonidine?
Measured: From enrollment to the end of treatment at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20261 Sep 2027

First posted8 Jul 2026
Study start10 Jun 2026
Primary completion10 Jul 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Primary Open-Angle Glaucoma (POAG)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07690397
Sponsor's protocol ID: CEI-002
Acronym: GLAUCO-TECH
Status last verified: Jul 2026
First submitted: 10 Jun 2026
Last updated: 8 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The information obtained in the study will be at the research center and the analysis will be carried out exclusively by the principal investigator and staff in charge at the Sigma Clinic.

Publications

Bachhuber F, Huss A, Senel M, Tumani H. Diagnostic biomarkers in tear fluid: from sampling to preanalytical processing. Sci Rep. 2021 May 12;11(1):10064. doi: 10.1038/s41598-021-89514-8.
PubMed 33980989
Ngo GH, Chadha M, Sun YJ, Yu G, Lee SH, Yeh TC, Almeida DRP, Bassuk AG, Mruthyunjaya P, Dufour A, Mahajan VB. Protocol to extract tear fluid for proteomics using Schirmer strips. STAR Protoc. 2025 Dec 19;6(4):104146. doi: 10.1016/j.xpro.2025.104146. Epub 2025 Oct 16.
PubMed 41108683
Stapleton F, Argueso P, Asbell P, Azar D, Bosworth C, Chen W, Ciolino JB, Craig JP, Gallar J, Galor A, Gomes JAP, Jalbert I, Jie Y, Jones L, Konomi K, Liu Y, Merayo-Lloves J, Oliveira FR, Perez VL, Rocha EM, Sullivan BD, Sullivan DA, Vehof J, Vitale S, Willcox M, Wolffsohn JS, Dogru M. TFOS DEWS III: Digest. Am J Ophthalmol. 2025 Nov;279:451-553. doi: 10.1016/j.ajo.2025.05.040. Epub 2025 Jun 4.
PubMed 40472874
Jones L, Craig JP, Markoulli M, Karpecki P, Akpek EK, Basu S, Bitton E, Chen W, Dhaliwal DK, Dogru M, Gomes JAP, Koehler M, Mehta JS, Perez VL, Stapleton F, Sullivan DA, Tauber J, Tong L, Trave-Huarte S, Wolffsohn JS; TFOS Collaborator Group. TFOS DEWS III: Management and Therapy. Am J Ophthalmol. 2025 Nov;279:289-386. doi: 10.1016/j.ajo.2025.05.039. Epub 2025 Jun 2.
PubMed 40467022
Wolffsohn JS, Benitez-Del-Castillo JM, Loya-Garcia D, Inomata T, Iyer G, Liang L, Pult H, Sabater AL, Starr CE, Vehof J, Wang MTM, Chen W, Craig JP, Dogru M, Perez VL, Stapleton F, Sullivan DA, Jones L; + TFOS collaborator group. TFOS DEWS III: Diagnostic Methodology. Am J Ophthalmol. 2025 Nov;279:387-450. doi: 10.1016/j.ajo.2025.05.033. Epub 2025 May 30.
PubMed 40451408
Chalmers RL, Begley CG, Caffery B. Validation of the 5-Item Dry Eye Questionnaire (DEQ-5): Discrimination across self-assessed severity and aqueous tear deficient dry eye diagnoses. Cont Lens Anterior Eye. 2010 Apr;33(2):55-60. doi: 10.1016/j.clae.2009.12.010. Epub 2010 Jan 25.
PubMed 20093066
Martinez-Perez P, Orozco-Beltran D, Pomares-Gomez F, Hernandez-Rizo JL, Borras-Gallen A, Gil-Guillen VF, Quesada JA, Lopez-Pineda A, Carratala-Munuera C. Validation and psychometric properties of the 8-item Morisky Medication Adherence Scale (MMAS-8) in type 2 diabetes patients in Spain. Aten Primaria. 2021 Feb;53(2):101942. doi: 10.1016/j.aprim.2020.09.007. Epub 2021 Jan 25.
PubMed 33508739
Benitez-Del-Castillo JM, Burgos-Blasco B. Prevalence of dry eye disease in Spain: A population-based survey (PrevEOS). Ocul Surf. 2025 Apr;36:126-133. doi: 10.1016/j.jtos.2025.01.006. Epub 2025 Jan 17.
PubMed 39828133
Martin R, Emo Research Group. Comparison of the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires for Dry Eye Symptom Assessment. Life (Basel). 2023 Sep 21;13(9):1941. doi: 10.3390/life13091941.
PubMed 37763343
Nattinen J, Aapola U, Nukareddy P, Uusitalo H. Clinical Tear Fluid Proteomics-A Novel Tool in Glaucoma Research. Int J Mol Sci. 2022 Jul 23;23(15):8136. doi: 10.3390/ijms23158136.
PubMed 35897711
Korenfeld M, Nichols KK, Goldberg D, Evans D, Sall K, Foulks G, Coultas S, Brazzell K. Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.
PubMed 32826644
Brinkman D, McSwiney T, James M. Comparing the tolerability of preservative-free tafluprost versus preserved latanoprost in the management of glaucoma and ocular hypertension - an observer blinded active-control trial. Ir J Med Sci. 2024 Oct;193(5):2589-2595. doi: 10.1007/s11845-024-03704-7. Epub 2024 May 15.
PubMed 38748195
Tapply I, Broadway DC. Improving Adherence to Topical Medication in Patients with Glaucoma. Patient Prefer Adherence. 2021 Jul 2;15:1477-1489. doi: 10.2147/PPA.S264926. eCollection 2021.
PubMed 34239297
Fea AM, Vallino V, Cossu M, Marica V, Novarese C, Reibaldi M, Petrillo F. Drug Delivery Systems for Glaucoma: A Narrative Review. Pharmaceuticals (Basel). 2024 Sep 2;17(9):1163. doi: 10.3390/ph17091163.
PubMed 39338326
Bacharach J, McLaurin EB, Silverstein S, Amrane M, Garrigue JS, Ismail D, Flynn WJ; Catiolanze Phase 2 study group. Efficacy and Safety of a Preservative-Free Latanoprost Cationic Emulsion in Patients with Open-Angle Glaucoma and Concurrent Ocular Surface Disease: A Randomized Phase 2 Study. J Ocul Pharmacol Ther. 2024 Nov;40(9):553-561. doi: 10.1089/jop.2024.0029. Epub 2024 Aug 16.
PubMed 39150378

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GLAUCO-TECH Study: Safety & Efficacy of Preservative-free vs. Preserved Dorzolamide-Timolol-Brimonidine. Impact on the Ocular Surface, Glaucoma Progression, Tear Proteomics, and AI/Chatbot-led Patient Follow-up.
ClinicalTrials.gov ID: NCT07690397
Acronym / sponsor ID: GLAUCO-TECH / CEI-002
Conditions: Primary Open-Angle Glaucoma (POAG), Ocular Hypertension
Keywords: GLAUCO-TECH, glaucoma therapy, molecular evaluation
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: TecnoquimicasIndustry (pharma, biotech, devices)
Study start: 10 Jun 2026 (actual)
Primary completion: 10 Jul 2027 (estimated)
Study completion: 1 Sep 2027 (estimated)
First posted: 8 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In patients with ocular hypertension or open-angle glaucoma, does treatment with the preservative-free dorzolamide-timolol-brimonidine combination improve ocular surface health?

Take their medication according to the investigator's instructions for at least 4 months
Attend follow-up appointments at the beginning, and every 2 months until 4 months have passed
Answer phone calls every 15 days
Complete the quality of life questionnaires within the timeframes defined by the investigator

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Preservative-free dorzolamide-timolol-brimonidine combination	Active comparator	Combination Product: Preservative dorzolamide-timolol-brimonidine combinationParticipants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.
Preservative dorzolamide-timolol-brimonidine combination	Other	Combination Product: Preservative-free dorzolamide-timolol-brimonidine combinationParticipants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Preservative-free dorzolamide-timolol-brimonidine combinationAlso: Biomarkers, OSDI, Educational Chatbot and Artificial Intelligence-Assisted Electronic Health RecordAt the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests. During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence. Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.	Combination product	Preservative dorzolamide-timolol-brimonidine combination
Preservative dorzolamide-timolol-brimonidine combinationAlso: Biomarkers, OSDI, Educational Chatbot and Artificial Intelligence-Assisted Electronic Health RecordAt the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests. During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence. Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.	Combination product	Preservative-free dorzolamide-timolol-brimonidine combination

Primary outcome

Changes in efficacy and quality of life and adherence questionnaires between two different formulations
Time frame: From enrollment to the end of treatment at 16 weeks
Are there significant differences in ocular surface health, adherence, quality of life, or clinical effectiveness between patients treated with preservative-free Dorzolamide-Timolol-Brimonidine and those receiving preservative-containing Dorzolamide-Timolol-Brimonidine?

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Background: PubMed 33980989Bachhuber F, Huss A, Senel M, Tumani H. Diagnostic biomarkers in tear fluid: from sampling to preanalytical processing. Sci Rep. 2021 May 12;11(1):10064. doi: 10.1038/s41598-021-89514-8.
Background: PubMed 41108683Ngo GH, Chadha M, Sun YJ, Yu G, Lee SH, Yeh TC, Almeida DRP, Bassuk AG, Mruthyunjaya P, Dufour A, Mahajan VB. Protocol to extract tear fluid for proteomics using Schirmer strips. STAR Protoc. 2025 Dec 19;6(4):104146. doi: 10.1016/j.xpro.2025.104146. Epub 2025 Oct 16.
Background: PubMed 40472874Stapleton F, Argueso P, Asbell P, Azar D, Bosworth C, Chen W, Ciolino JB, Craig JP, Gallar J, Galor A, Gomes JAP, Jalbert I, Jie Y, Jones L, Konomi K, Liu Y, Merayo-Lloves J, Oliveira FR, Perez VL, Rocha EM, Sullivan BD, Sullivan DA, Vehof J, Vitale S, Willcox M, Wolffsohn JS, Dogru M. TFOS DEWS III: Digest. Am J Ophthalmol. 2025 Nov;279:451-553. doi: 10.1016/j.ajo.2025.05.040. Epub 2025 Jun 4.
Background: PubMed 40467022Jones L, Craig JP, Markoulli M, Karpecki P, Akpek EK, Basu S, Bitton E, Chen W, Dhaliwal DK, Dogru M, Gomes JAP, Koehler M, Mehta JS, Perez VL, Stapleton F, Sullivan DA, Tauber J, Tong L, Trave-Huarte S, Wolffsohn JS; TFOS Collaborator Group. TFOS DEWS III: Management and Therapy. Am J Ophthalmol. 2025 Nov;279:289-386. doi: 10.1016/j.ajo.2025.05.039. Epub 2025 Jun 2.
Background: PubMed 40451408Wolffsohn JS, Benitez-Del-Castillo JM, Loya-Garcia D, Inomata T, Iyer G, Liang L, Pult H, Sabater AL, Starr CE, Vehof J, Wang MTM, Chen W, Craig JP, Dogru M, Perez VL, Stapleton F, Sullivan DA, Jones L; + TFOS collaborator group. TFOS DEWS III: Diagnostic Methodology. Am J Ophthalmol. 2025 Nov;279:387-450. doi: 10.1016/j.ajo.2025.05.033. Epub 2025 May 30.
Background: PubMed 20093066Chalmers RL, Begley CG, Caffery B. Validation of the 5-Item Dry Eye Questionnaire (DEQ-5): Discrimination across self-assessed severity and aqueous tear deficient dry eye diagnoses. Cont Lens Anterior Eye. 2010 Apr;33(2):55-60. doi: 10.1016/j.clae.2009.12.010. Epub 2010 Jan 25.
Background: PubMed 33508739Martinez-Perez P, Orozco-Beltran D, Pomares-Gomez F, Hernandez-Rizo JL, Borras-Gallen A, Gil-Guillen VF, Quesada JA, Lopez-Pineda A, Carratala-Munuera C. Validation and psychometric properties of the 8-item Morisky Medication Adherence Scale (MMAS-8) in type 2 diabetes patients in Spain. Aten Primaria. 2021 Feb;53(2):101942. doi: 10.1016/j.aprim.2020.09.007. Epub 2021 Jan 25.
Background: PubMed 39828133Benitez-Del-Castillo JM, Burgos-Blasco B. Prevalence of dry eye disease in Spain: A population-based survey (PrevEOS). Ocul Surf. 2025 Apr;36:126-133. doi: 10.1016/j.jtos.2025.01.006. Epub 2025 Jan 17.
Background: PubMed 37763343Martin R, Emo Research Group. Comparison of the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires for Dry Eye Symptom Assessment. Life (Basel). 2023 Sep 21;13(9):1941. doi: 10.3390/life13091941.
Background: PubMed 35897711Nattinen J, Aapola U, Nukareddy P, Uusitalo H. Clinical Tear Fluid Proteomics-A Novel Tool in Glaucoma Research. Int J Mol Sci. 2022 Jul 23;23(15):8136. doi: 10.3390/ijms23158136.
Background: PubMed 32826644Korenfeld M, Nichols KK, Goldberg D, Evans D, Sall K, Foulks G, Coultas S, Brazzell K. Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.
Background: PubMed 38748195Brinkman D, McSwiney T, James M. Comparing the tolerability of preservative-free tafluprost versus preserved latanoprost in the management of glaucoma and ocular hypertension - an observer blinded active-control trial. Ir J Med Sci. 2024 Oct;193(5):2589-2595. doi: 10.1007/s11845-024-03704-7. Epub 2024 May 15.
Individual participant dataSharing planned: No. The information obtained in the study will be at the research center and the analysis will be carried out exclusively by the principal investigator and staff in charge at the Sigma Clinic.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlos Cifuentes, MD principal investigator

Clinica Sigma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in efficacy and quality of life and adherence questionnaires between two different formulations (time frame: From enrollment to the end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07690397, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.