DEDNCT07571330
Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.
A study testing Punctal plug occlusion in people with DED and Aqueous-deficient Dry Eye Disease, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DED, Aqueous-deficient Dry Eye Disease
- What is being tested?
- Punctal plug occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 12 Feb 2026to 1 Nov 2026
- Phase
- Interventional
- 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
- Patients of both sexes
- One or both eyes may be included
- Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination
- Functional superior lacrimal punctum
- Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.)
- Age >18 years
- OSDI score >13 and one of the following signs: Tear film markers (Fluorescein tear break up-time <5, First non-invasive tear breakup time <10, Schirmer test without anesthesia <10 mm, Schirmer test with anesthesia <10 mm), Ocular surface markers (corneal staining >5 spots or conjunctival staining >9 spots).
Who cannot join
- Active ocular surface infection.
- Patients who are unwilling to participate or to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Ophthalmology Department
Monterrey, Nuevo León, 64460
Karim Mohamed-Noriega, Dr. med., +52 8113404960 ext. 8514, karim.mohamednrg@uanl.edu.mx
About this study
Official title: Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.
This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.
Read the detailed description
This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion
- Conditions
- DED, Aqueous-deficient Dry Eye Disease
- Being tested
- Punctal plug occlusion
- Keywords
- Aqueous-deficient dry eye disease, DED, Punctual plug, Superior punctual plug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punctal plug occlusionProcedure or surgery
Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.
| Study group | Role | What they receive |
|---|---|---|
| 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who | Experimental | 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum. Receives: Procedure: Punctal plug occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Effectiveness
To evaluate signs and symptoms of dry eye, after superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum at baseline, 2 weeks, 4 weeks, 3 months and 6 months
Measured: Baseline, 2 weeks, 4 weeks, 3 months and 6 months
Secondary outcomes (12)
Change in lower tear meniscus heigh
Change in lower tear meniscus height measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.
Measured: Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus area
Change in lower tear meniscus area measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.
Measured: Baseline to 3 months after upper punctal plug placement.
Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI)
The OSDI is a validated 12-item questionnaire evaluating dry eye symptoms and their impact on vision-related functioning across three domains: ocular symptoms, visual function, and environmental triggers. Each item is scored on a 5-point scale (0 = none of the time to 4 = all of the time). The total OSDI score is calculated as:
OSDI= number of questions answered (sum of scores)×25
Scores range from 0 to 100, with higher scores indicating greater disability. Severity categories are: normal (0-12), mild (13-22), moderate (23-32), and severe (33-100).
Measured: Baseline to 3 months after upper punctal plug placement.
Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale.
The SANDE is a validated, patient-reported outcome measuring dry eye symptom burden using two 100-mm visual analog scales assessing frequency and severity of symptoms (0 = none, 100 = maximal). The composite SANDE score is calculated as the square root of the product of frequency and severity scores:
Higher scores indicate worse symptoms.
Measured: Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time (TFBUT).
Change in tear film break-up time measured with fluorescein after upper punctal plug placement.
Measured: Baseline to 3 months after upper punctal plug placement.
Change in non-invasive tear break-up time (NIBUT).
Change in non-invasive tear break-up time measured using Keratograph after upper punctal plug placement.
Measured: Baseline to 3 months after upper punctal plug placement.
Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS).
The SICCA OSS is a standardized clinical grading system developed by the Sjögren's International Collaborative Clinical Alliance to quantify ocular surface epithelial damage using vital dyes. The score combines fluorescein corneal staining and lissamine green conjunctival staining in each eye.
Measured: Baseline to 3 months after upper punctal plug placement.
Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score
The NEI corneal fluorescein staining score is a standardized slit-lamp-based grading system used to quantify corneal epithelial damage after fluorescein instillation. The cornea is divided into five regions (central, superior, inferior, nasal, and temporal). Each region is graded on a 0 to 3 scale based on staining density and extent:
0 = no staining
- = sparse punctate staining
- = moderate/dense punctate staining
- = severe staining or coalescent areas
The total NEI score is the sum of all regions, ranging from 0 to 15, with higher scores indicating greater corneal epithelial damage.
Measured: Baseline to 3 months after upper punctal plug placement.
Change in Schirmer I test results.
Change in tear production measured using the Schirmer I test with and without anesthesia after upper punctal plug placement.
Measured: Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity.
Change in corneal sensitivity measured by corneal esthesiometry after upper punctal plug placement.
Measured: Baseline to 3 months after upper punctal plug placement.
Incidence of epiphora after upper punctal plug placement.
Incidence of epiphora reported after upper punctal plug placement during the follow-up period.
Measured: Up to 3 months after upper punctal plug placement.
Upper punctal plug retention rate.
Proportion of upper punctal plugs remaining in place during the follow-up period after placement.
Measured: Up to 3 months after upper punctal plug placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start12 Feb 2026
- Primary completion1 Oct 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DEDStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, consecutive, interventional case series study of patients with aqueous-deficient dry eye disease.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
- Investigators
- Karim Mohamed-Noriega, Dr. med., Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571330
- Sponsor's protocol ID
- OF25-00001
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiu W, Liu Z, Ao M, Li X, Wang W. Punctal plugs versus artificial tears for treating primary Sjogren's syndrome with keratoconjunctivitis SICCA: a comparative observation of their effects on visual function. Rheumatol Int. 2013 Oct;33(10):2543-8. doi: 10.1007/s00296-013-2769-1. Epub 2013 May 7.
PubMed 23649850Perez VL, Chen W, Craig JP, Dogru M, Jones L, Stapleton F, Wolffsohn JS, Sullivan DA. TFOS DEWS III: Executive Summary. Am J Ophthalmol. 2026 Feb;282:135-145. doi: 10.1016/j.ajo.2025.09.035. Epub 2025 Sep 24.
PubMed 41005521Marcet MM, Shtein RM, Bradley EA, Deng SX, Meyer DR, Bilyk JR, Yen MT, Lee WB, Mawn LA. Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Aug;122(8):1681-7. doi: 10.1016/j.ophtha.2015.04.034. Epub 2015 May 30.
PubMed 26038339Lanza NL, Valenzuela F, Perez VL, Galor A. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye. Ocul Surf. 2016 Apr;14(2):189-95. doi: 10.1016/j.jtos.2015.10.004. Epub 2016 Feb 2.
PubMed 26850527Kaido M, Ishida R, Dogru M, Tsubota K. Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease. Am J Ophthalmol. 2013 Apr;155(4):648-653, 653.e1. doi: 10.1016/j.ajo.2012.10.024. Epub 2013 Jan 11.
PubMed 23317650Hallali G, Guindolet D, Gabison EE, Cochereau I, Doan S. Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye. Cornea. 2024 Jul 1;43(7):890-894. doi: 10.1097/ICO.0000000000003477. Epub 2024 Jan 30.
PubMed 38289716Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
PubMed 28736335Chen F, Wang J, Chen W, Shen M, Xu S, Lu F. Upper punctal occlusion versus lower punctal occlusion in dry eye. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5571-7. doi: 10.1167/iovs.09-5097. Epub 2010 May 12.
PubMed 20463310Chen F, Shen M, Chen W, Wang J, Li M, Yuan Y, Lu F. Tear meniscus volume in dry eye after punctal occlusion. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1965-9. doi: 10.1167/iovs.09-4349. Epub 2009 Nov 20.
PubMed 19933200Burgess PI, Koay P, Clark P. SmartPlug versus silicone punctal plug therapy for dry eye: a prospective randomized trial. Cornea. 2008 May;27(4):391-4. doi: 10.1097/ICO.0b013e318160d030.
PubMed 18434839Boldin I, Klein A, Haller-Schober EM, Horwath-Winter J. Long-term follow-up of punctal and proximal canalicular stenoses after silicone punctal plug treatment in dry eye patients. Am J Ophthalmol. 2008 Dec;146(6):968-72.e1. doi: 10.1016/j.ajo.2008.06.028. Epub 2008 Aug 23.
PubMed 18723140Balaram M, Schaumberg DA, Dana MR. Efficacy and tolerability outcomes after punctal occlusion with silicone plugs in dry eye syndrome. Am J Ophthalmol. 2001 Jan;131(1):30-6. doi: 10.1016/s0002-9394(00)00620-6.
PubMed 11162976Ali MJ, Singh S. Optical coherence tomography and the proximal lacrimal drainage system: a major review. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3197-3208. doi: 10.1007/s00417-021-05175-3. Epub 2021 Apr 16.
PubMed 33861367Ahn H, Ji YW, Jun I, Kim TI, Lee HK, Seo KY. Comparison of Treatment Modalities for Dry Eye in Primary Sjogren's Syndrome. J Clin Med. 2022 Jan 17;11(2):463. doi: 10.3390/jcm11020463.
PubMed 35054155
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.
- ClinicalTrials.gov ID
- NCT07571330
- Acronym / sponsor ID
- OF25-00001
- Conditions
- DED, Aqueous-deficient Dry Eye Disease
- Keywords
- Aqueous-deficient dry eye disease, DED, Punctual plug, Superior punctual plug
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 6 May 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.
This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.
Detailed description
This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, consecutive, interventional case series study of patients with aqueous-deficient dry eye disease.
| Arm | Type | Receives |
|---|---|---|
| 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who | Experimental | Procedure: Punctal plug occlusion1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes
- One or both eyes may be included
- Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination
- Functional superior lacrimal punctum
- Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.)
Key exclusion criteria (2 listed)
- Active ocular surface infection.
- Patients who are unwilling to participate or to provide written informed consent.
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 |
|---|---|---|
| Punctal plug occlusionSuperior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum. | Procedure or surgery | 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who |
Primary outcome
1. Effectiveness
Time frame: Baseline, 2 weeks, 4 weeks, 3 months and 6 months
To evaluate signs and symptoms of dry eye, after superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum at baseline, 2 weeks, 4 weeks, 3 months and 6 months
12 secondary outcomes
Change in lower tear meniscus heigh
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus area
Time frame: Baseline to 3 months after upper punctal plug placement.
Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI)
Time frame: Baseline to 3 months after upper punctal plug placement.
Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time (TFBUT).
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in non-invasive tear break-up time (NIBUT).
Time frame: Baseline to 3 months after upper punctal plug placement.
Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS).
Time frame: Baseline to 3 months after upper punctal plug placement.
Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in Schirmer I test results.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity.
Time frame: Baseline to 3 months after upper punctal plug placement.
Incidence of epiphora after upper punctal plug placement.
Time frame: Up to 3 months after upper punctal plug placement.
Upper punctal plug retention rate.
Time frame: Up to 3 months after upper punctal plug placement.
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 16 Oct 2026.
- Background: PubMed 23649850Qiu W, Liu Z, Ao M, Li X, Wang W. Punctal plugs versus artificial tears for treating primary Sjogren's syndrome with keratoconjunctivitis SICCA: a comparative observation of their effects on visual function. Rheumatol Int. 2013 Oct;33(10):2543-8. doi: 10.1007/s00296-013-2769-1. Epub 2013 May 7.
- Background: PubMed 41005521Perez VL, Chen W, Craig JP, Dogru M, Jones L, Stapleton F, Wolffsohn JS, Sullivan DA. TFOS DEWS III: Executive Summary. Am J Ophthalmol. 2026 Feb;282:135-145. doi: 10.1016/j.ajo.2025.09.035. Epub 2025 Sep 24.
- Background: PubMed 26038339Marcet MM, Shtein RM, Bradley EA, Deng SX, Meyer DR, Bilyk JR, Yen MT, Lee WB, Mawn LA. Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Aug;122(8):1681-7. doi: 10.1016/j.ophtha.2015.04.034. Epub 2015 May 30.
- Background: PubMed 26850527Lanza NL, Valenzuela F, Perez VL, Galor A. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye. Ocul Surf. 2016 Apr;14(2):189-95. doi: 10.1016/j.jtos.2015.10.004. Epub 2016 Feb 2.
- Background: PubMed 23317650Kaido M, Ishida R, Dogru M, Tsubota K. Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease. Am J Ophthalmol. 2013 Apr;155(4):648-653, 653.e1. doi: 10.1016/j.ajo.2012.10.024. Epub 2013 Jan 11.
- Background: PubMed 38289716Hallali G, Guindolet D, Gabison EE, Cochereau I, Doan S. Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye. Cornea. 2024 Jul 1;43(7):890-894. doi: 10.1097/ICO.0000000000003477. Epub 2024 Jan 30.
- Background: PubMed 28736335Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
- Background: PubMed 20463310Chen F, Wang J, Chen W, Shen M, Xu S, Lu F. Upper punctal occlusion versus lower punctal occlusion in dry eye. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5571-7. doi: 10.1167/iovs.09-5097. Epub 2010 May 12.
- Background: PubMed 19933200Chen F, Shen M, Chen W, Wang J, Li M, Yuan Y, Lu F. Tear meniscus volume in dry eye after punctal occlusion. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1965-9. doi: 10.1167/iovs.09-4349. Epub 2009 Nov 20.
- Background: PubMed 18434839Burgess PI, Koay P, Clark P. SmartPlug versus silicone punctal plug therapy for dry eye: a prospective randomized trial. Cornea. 2008 May;27(4):391-4. doi: 10.1097/ICO.0b013e318160d030.
- Background: PubMed 18723140Boldin I, Klein A, Haller-Schober EM, Horwath-Winter J. Long-term follow-up of punctal and proximal canalicular stenoses after silicone punctal plug treatment in dry eye patients. Am J Ophthalmol. 2008 Dec;146(6):968-72.e1. doi: 10.1016/j.ajo.2008.06.028. Epub 2008 Aug 23.
- Background: PubMed 11162976Balaram M, Schaumberg DA, Dana MR. Efficacy and tolerability outcomes after punctal occlusion with silicone plugs in dry eye syndrome. Am J Ophthalmol. 2001 Jan;131(1):30-6. doi: 10.1016/s0002-9394(00)00620-6.
Related trials for DED
RecruitingPhase 2
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Dry Eye Disease (DED)
RecruitingObservational study
Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study
Periodontitis, Dry Eye Disease (DED)
Active, not recruitingPhase 4
Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery
Dry Eye Disease (DED)
Not yet recruiting
Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs
Myopia, Dry Eye Disease (DED)
Not yet recruiting
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
Digital Health, Maternal Health Services
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.
Karim Mohamed-Noriega, Dr. med. principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punctal plug occlusion in people with DED and Aqueous-deficient Dry Eye Disease, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Oct 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 Mexico. 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.
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?
Contact Karim Mohamed-Noriega, Dr. med. (+52 8113404960 ext. 8514, karim.mohamednr@uanl.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Effectiveness (time frame: Baseline, 2 weeks, 4 weeks, 3 months and 6 months). 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 NCT07571330, which also lists 14 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 16 Oct 2026.