Dry Eye Disease

21

Review clinical trials related to Dry Eye Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops

The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II lubricant eye drops in subjects experiencing dry eye (DE) symptoms.

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Alcon ResearchUpdated: Jun 15, 2026Locations: 6
Eligibility criteria

Able to read, understand, and sign an Institutional Review Board (IRB)/Independe... [+4]

Any known allergic reactions to the study products or its ingredients. [+4]

Status: Not yet recruiting

Phase III Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Placebo for Moderate to Severe Dry Eye

Prospective, multicenter, randomized, vehicle-controlled, double-masked, study of CAM-101 topical ophthalmic solution compared to vehicle control followed by crossover to long-term follow-up open-label treatment with CAM-101 for one year.

Participants needed: 475
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Cambium Bio LimitedUpdated: Jun 12, 2026
Eligibility criteria

Male or female subjects who at the time of consent are 18 years of age or older,... [+10]

Any abnormal lid anatomy or blinking function in either eye. [+27]

Status: Recruiting

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY02 non-inferior to TRB02 in terms of signs of DED? * Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED? Participants will be asked to: * Visit the trial site at 4 different timepoints * Use the allocated study treatment everyday until the end of the study (during 3 months) * Be examined by the investigator * Complete several questionnaires * Return unused study treatment. Researchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: TRB Chemedica International SAUpdated: Jun 3, 2026Locations: 5
Eligibility criteria

At least a 3-month documented history of bilateral dry eye syndrome needing arti... [+3]

Wear of contact lenses starting within the last 2 months; [+12]

Status: Recruiting

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY01 non-inferior to SVS20 in terms of signs of DED? * Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED? Participants will be asked to: * Visit the trial site at 4 different timepoints * Use the allocated study treatment everyday until the end of the study (during 3 months) * Be examined by the investigator * Complete several questionnaires * Return unused study treatment. Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: TRB Chemedica International SAUpdated: Jun 3, 2026Locations: 2
Eligibility criteria

At least a 3-month documented history of bilateral dry eye syndrome needing arti... [+3]

Wear of contact lenses starting within the last 2 months; [+12]

Status: Recruiting

Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease

This clinical trial aims to preliminarily evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell small extracellular vesicle eye drops in patients with dry eye disease. 1. Human mesenchymal stem cell small extracellular vesicle eye drops: Administer one drop each time, 4 times daily, for a treatment duration of 4 weeks. 2. During treatment, subjects will be followed up and undergo examinations and related tests weekly. 3. After completion of treatment, follow-up visits will be conducted every 2 weeks for a total of 2 visits. 4. Subsequently, subjects will enter a long-term follow-up period, with follow-up assessments at 3 months and 6 months to observe longer-term safety and efficacy. 5. Subjects shall record medication usage and any possible adverse reactions.

Participants needed: 20
Trial details
Phase: Early Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital of Xiamen UniversityUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

Subjects who voluntarily participate and sign the informed consent form, are wil... [+3]

Subjects with current ocular herpes or any other ocular infection or inflammatio... [+21]

Status: Recruiting

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease

A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

Participants needed: 423
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Bausch & Lomb IncorporatedUpdated: Mar 13, 2026Locations: 32
Eligibility criteria

Voluntarily provide written informed consent [+6]

Known allergy or sensitivity to any study treatment (or any of its components) [+4]

Status: Recruiting

An Evaluation of the Safety and Tolerability of Ocular Lubricants

The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.

Participants needed: 148
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Alcon ResearchUpdated: Mar 11, 2026Locations: 4
Eligibility criteria

Subject must be willing and able to understand and sign an ethics committee appr... [+4]

Has any known active ocular disease and/or infection. [+4]

Status: Not yet recruiting

A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment of Dry Eye Disease (DED) Related to Meibomian Gland Dysfunction (MGD)

Perfluorohexyloctane eye drops is the only drug in China approved for treating Dry Eye Disease (DED) related to Meibomian Gland Dysfunction (MGD), its efficacy and safety in the clinical practice of treating DED related to MGD in the real world, whether in combination with or without various other treatment methods (other drugs or physical therapy) , remain to be explored. This study aims to collect data on the treatment of DED related to MGD with perfluorohexyloctane under real medical conditions. Through analysis, it seeks to obtain clinical evidence of the product's application value and potential benefits or risks, providing evidence for the treatment of DED elated to MGD with perfluorohexyloctane under real medical conditions.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Xiamen Ophthalmology Center Affiliated to Xiamen UniversityUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

Patients who meet the diagnostic criteria for meibomian gland dysfunction (MGD)... [+3]

Patients who have a history of allergy to any component of the drugs or tests in... [+3]

Status: Recruiting

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. We will measure the iron content in the tears and see if it correlates with standard dry eye test results and symptom scores.

Participants needed: 52
Trial details
Age: 18-70Biological sex: AllType: ObservationalSponsor: Shanghai Changzheng HospitalUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Aged between 18 and 70 years, inclusive. [+1]

History or clinical suspicion of significant systemic conditions: hematologic di... [+7]

Status: Recruiting

2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD

Evaluate and study the immunologic changes to the ocular surface in cancer patients.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of Maryland, BaltimoreUpdated: Feb 3, 2026Locations: 1
Eligibility criteria

Adult patients (≥ 18 years of age) who visit the Eye clinic either in the UMGCCC... [+1]

Vulnerable populations: neonates, children, prisoners, institutionalized individ... [+2]

Status: Recruiting

Vit-A-Vision® Clinical Investigation

Symptoms of ocular discomfort include dryness, burning, stinging, photophobia, foreign body sensation and contact lens intolerance. These symptoms may affect basic daily activities, such as reading, driving, and working with computers. In case of moderate to severe conditions, dry eye disease is also associated with significant pain. Dry eye disease (DED) affects hundreds of millions of people throughout the world and is one of the most frequent causes of patient visits to eye care practitioners. Diagnosing, staging and determining the efficacy of therapy in DED is often challenging due to low correlation between signs and symptoms. Furthermore, its management is complicated because of its multifactorial aetiology. In general, management approaches begin with conventional, low-risk and easily accessible patient-applied therapies such as over-the-counter lubricants for early-stage disease, and progress to more advanced therapies for more severe forms of DED. In this regard, tear supplementation with ocular lubricants (artificial tears) is considered the first-line therapy and is often the only therapy used in mild to moderate disease. They are used in all stages of dry eye, either alone (in mild to moderate disease) or in combination with other treatments (in moderate to severe disease). Most tear supplements act as lubricants. Other actions may include replacement of deficient tear constituents, dilution of proinflammatory substances, reduction of tear osmolarity and protection against osmotic stress. A wide variety of artificial tear products is currently available. These products differ with respect to several variables, that include electrolyte composition, osmolarity/osmolality, viscosity, the presence or absence of preservatives and the presence or absence of compatible solutes. Although they are all considered as standard of care in treatment of dry eye disease, the effects of many of the available products have not been evaluated in clinical investigations. Vit-A-Vision is an ointment for ophthalmic application that relieves symptoms such as burning, irritation, slight irritation, dryness or tiredness of the eyes.

Participants needed: 77
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: OmniVision GmbHUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

At least 18 years old [+5]

Known hypersensitivity (allergy) to any of the ingredients of Vit-A-Vision: vase... [+20]

Status: Not yet recruiting

A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients

This is a phase III, multicenter, randomized, double-masked, Active-controlled design. The aims to confirm previous findings of the efficacy and safety of CsA-PG Ophthalmic Gel by comparing it to CsA Ophthalmic Gel for treating dry eye symptoms.

Participants needed: 396
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Updated: Apr 29, 2025
Eligibility criteria

Be at least 18 years of age, male or female; [+6]

Clinical diagnosis or history of any clinically significant ocular diseases/diso... [+34]

Status: Not yet recruiting

Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye

This clinical study involves patients with Dry Eye Disease (DED) who are visiting an ophthalmology outpatient clinic. Eligible participants must have an Ocular Surface Disease Index (OSDI) score ≥14 and \<50, and at least one positive diagnostic test: tear break-up time (TBUT) \<7 seconds, Schirmer I test \<10 mm/5 min, or positive corneal staining based on the Oxford grading scale. At baseline, tear film thickness will be measured using Pentacam imaging. Participants will then receive Proluxx eye spray, applied four times daily for 28 days. After this treatment period, a follow-up examination with all baseline assessments will be repeated.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital Sestre MilosrdniceUpdated: May 2, 2025Locations: 1
Eligibility criteria

Ocular Surface Disease Index (OSDI) score between 14 and 50 and at least one pos...

use of systemic or topical corticosteroids, active ocular infection, or ocular s...

Status: Recruiting

Ocular Microbiome and Immune System in Dry Eyes

The primary objectives of this study are the characterization of the ocular microbiome as well as of the local immune system in participants with and without dry eye disease. Secondary objectives are the identification of differences in the ocular microbiome as well as in the immune system between participants with and without dry eye disease to ultimately find associations between the ocular microbiome and the immune system in dry eye disease.

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Insel Gruppe AG, University Hospital BernUpdated: Apr 1, 2025Locations: 1
Eligibility criteria

Willing to sign informed consent [+1]

Not willing or able to sign informed consent [+4]

Status: Not yet recruiting

Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®

This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.

Participants needed: 32
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Laboratorios Sophia S.A de C.V.Updated: Mar 19, 2025
Eligibility criteria

Having the ability to voluntarily give their signed informed consent. [+8]

History of hypersensitivity to any of the components of the drugs under investig... [+22]

Status: Not yet recruiting

Characterization of Subjective Discomfort in Patients With Tear Dysfunction

Characterization of subjective discomfort/pain in patients with ocular surface dysfunction in association with clinical and laboratory parameters, for a better understanding of the underlying pathogenic mechanisms.

Participants needed: 12,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaUpdated: Feb 11, 2025Locations: 1
Eligibility criteria

adult patients with suspected or diagnosed DED

nothing

Status: Recruiting

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease. Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Participants needed: 256
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Beijing Tongren HospitalUpdated: Nov 20, 2024Locations: 1
Eligibility criteria

Age >=18 and Age <=65. [+5]

History systemic autoimmune diseases and ocular/periocular malignancy. [+3]

Status: Not yet recruiting

Effect of Artificial Tears on Ocular Biometry Parameters

Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs). This prospective and before-and-after self-control study will recruit 100 patients.

Participants needed: 100
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: He Eye HospitalUpdated: Oct 24, 2024
Eligibility criteria

The eyes cannot fixate on the fixation lamp (such as children, nystagmus disease... [+8]

Status: Recruiting

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction. Methods: We enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.OSDI score, TBUT, Schirmer I, tCFS, MGD score, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Participants needed: 128
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Beijing Tongren HospitalUpdated: Sep 19, 2024Locations: 2
Eligibility criteria

Age >=18 and Age <=75. [+1]

History of depression, tumors, thyroid disease, diabetes, cardiac diseases. [+2]

Status: Not yet recruiting

iTear Single-center, Open-label, Single-arm Study

This study aims to evaluate the effectiveness and safety of a device, iTEAR100 Neurostimulator (the device), which is designed to help people with Dry Eye Disease (DED) who are not satisfied with using artificial tears. The study will last three months and take place at one location. Thirty participants will use the iTEAR100 Neurostimulator, which stimulates the outside of the nose to help with dry eye symptoms. Participants will have three main visits: one at the start (Day 0), one after 30 days (Day 30), and one at the end of the study (Day 90). For the first 30 days, they will use the device twice a day for 30 seconds on each side of the nose. After that, they will use it as needed for the next 60 days. Before starting the treatment, participants will undergo tests to measure their initial eye condition. The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90. Participants will also fill out a questionnaire about their eye symptoms on Day 14. The main measure of success is how much the participants' symptoms improve on the Ocular Surface Disease Index (OSDI) from Day 0 to Day 30. Other measures include changes in tear production, tear quality, and eye health from Day 0 to Days 30 and 90. Participants' safety will be monitored by tracking any adverse events (side effects) throughout the study.

Participants needed: 30
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Jul 29, 2024Locations: 1
Eligibility criteria

Provided informed consent, approved by the Institutional Review Board (IRB), to... [+3]

Used extranasal or intranasal neurostimulator within 30 days of Visit 1. [+2]

Status: Recruiting

The Pattern of Dry Eye Disease After Cataract Surgery

This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.

Participants needed: 100
Trial details
Age: 50-90Biological sex: AllType: ObservationalSponsor: Lithuanian University of Health SciencesUpdated: Mar 7, 2024Locations: 1
Eligibility criteria

Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemuls... [+2]

Patient expressed his wish to not participate in the study or discontinue it whe... [+9]