Dry Eye DiseasePhase 3NCT04711642
Comprehensive Study on Dry Eye and Ocular Surface Disease Prior and After Cataract Surgery
A Phase 3 study testing The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod) in people with Dry Eye Disease and Dry Eye Syndrome, run by Fundación Oftalmológica Los Andes.
Trial summary
Ocular surface disease (OSD), particularly dry eye, is one of the most common conditions seen by ophthalmologists. Dry eye (DE) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear instability. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dry Eye Disease, Dry Eye Syndrome, Evaporative Dry Eye
- What is being tested?
- The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 15 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Indication of phacoemulsification for refractive purposes or for the presence of visually significant cataract.
- Absence of intraoperative or postoperative complications of phacoemulsification
- Willing to participate in the study (signed informed consent)
Who cannot join
- Ocular surgeries within the previous 6 months.
- Contact lenses user.
- Severe blepharitis.
- Palpebral malposition and secondary dry eye
- History of filamentary keratitis, corneal neovascularization, or herpetic keratitis within previous 3 months.
- Hypersensitivity to investigated substances or diagnostic stains used.
- Antiglaucomatous topical medication
- Artificial tears with instillation frequency greater than 3 times a day in the last week
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comprehensive Study on Dry Eye and Ocular Surface Disease Prior and After Cataract Surgery: Effects of Treatment on Dry Eye and Inflammatory Biomarkers.
Ocular surface disease (OSD), particularly dry eye, is one of the most common conditions seen by ophthalmologists. Dry eye (DE) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear instability. DE significantly reduces quality of life and affects 5-30% of the population. As the proportion of individuals over age 60 increases because of greater life expectancies, we can anticipate the number of people with dry eye will also increase, which represents a major challenging for aging societies, like the Chilean one.
In the last few years clinical research on OSD is being intensely focused on diagnostic criteria, treatment strategies, methods used in diagnosis and better correlations between symptoms and clinical test results. All these lines of interest aim to improve the understanding of alterations and consequences occurring in the ocular surface disorders. Diagnostic testing is greatly valuable both for the detection of early changes due to DE and also to grade the severity of surface disease. The most commonly performed tests include the Schirmer test, tear break up time (TBUT), and ocular surface staining. However, newer point-of-care diagnostics tests such as tear osmolarity and matrix metalloprotease-9 (MMP-9) have been shown to have a high sensitivity and specificity in diagnosing ocular surface dysfunction.
Read more
Given that ocular surface dysfunction has been shown to have an adverse impact on visual function and can worsen after surgery, it is critical to identify and address any tear film and ocular surface abnormalities before cataract surgery. In the setting of preoperative cataract surgery planning, DE disease and meibomian gland dysfunction can impair critical refractive measures such as keratometry values worsening surgical outcomes.
To the best of our knowledge there are no ongoing or published studies that have evaluated DE and OSD as evidenced by either an abnormal tear-film parameter (elevated MMP-9 or abnormal osmolarity), or corneal surface and meibography evaluation findings (using novel non-invasive technology) in patients previous and after cataract surgery.
Read the detailed description
A prospective randomized study has been designed to assess and characterize OSD/DE in consecutive patients presenting for cataract surgery evaluation and to identify eventual changes on biomarkers of the tear film of the same population postoperatively. At the same time, 2 different postoperative eye drops regimen will be evaluated in order to determine its impact on postoperative OSD/DE.
All group of patients will be subjected to Dry Eye assessment using diagnosis criteria and methodologies recommended by the 2017 Dry Eye Workshop (DEWS II) (2), which includes the assessment of a battery of symptoms (OSDI questionnaire), signs (tear meniscus height, corneal and conjunctival lissamine green/fluorescein staining), laboratory tests (Schirmer I, TBUT assessment, tear osmolarity, tear MMP-9, meibography, ocular redness, lipid layer thickness) and physical examination (lid, meibum gland assessment). This assessment will be carried out in all groups preoperative and at postoperative week 4 and postoperative week 12.
Altogether, by identifying definite changes either in novel tear film biomarkers or non invasive ocular tests of patients subjected to cataract surgery, we expect to contribute to the understanding of the pathophysiology of the OSD and Dry Eye associated to cataract surgery and to give lights on the utility of those changes as biomarkers in diagnosis and therapy assessment in these conditions committing the ocular surface.
The research hypothesis is that there is a high prevalence of ocular surface dysfunction among patients presenting for cataract surgery as measured by point-of-care objective tear tests and cataract surgery results in altered ocular surface in a major fraction of patients. Dry eye symptoms are not necessary associated with objective signs in the ocular surface, but are less in the group of patients treated with associated lubricant eyedrops postoperatively. Patients more symptomatic in the postoperative period tend to have multiple preoperative OSD/DE biomarkers altered.
Consecutive patients presenting for cataract surgery evaluation will be recruited at the Fundacion Oftalmologica Los Andes (FOLA) Ophthalmology Clinic (Santiago, Chile). Patients will be eligible according to inclusion and exclusion criteria indicated. Eligible patients will be invited to participate voluntary in the study. The study will comprise three groups with 30-35 patients per group. Dry eye patients will be diagnosed according to TFOS DEWS II report and to the recommendations of the Dry Eye Workshop of 2017. It will basically consist of: a) patient history: symptoms and signs (e.g. ocular irritation, dryness or foreign body sensation, redness, etc), exacerbating conditions, duration of symptoms, etc., will be obtained by using the Ocular Surface Disease Index (OSDI). b) physical examination: visual acuity measurement, external examination and slit lamp biomicroscopy (tear film, tear meniscus, eyelashes, eyelid margins, conjunctiva, cornea, lens and retina). c) Diagnostic tests: Tear film osmolarity (using Tearlab), Tear film MMP-9 levels (using InflammaDry). Non-invasive tests will be performed using Keratograph 5M, which includes: non-invasive tear film break up time tear meniscus height, lipid layer thickness, ocular redness and meibography.
The study will comprise three groups. Each group will comprise 30-35 patients. Each of the 100 patients will be featured by a list of clinical parameters (ocular signs and symptoms and laboratory tests used conventionally for Dry Eye diagnostic). It is expected to observe differences in parameters before and after cataract surgery and between the control group and the two interventional groups. Association of those differences with the type of postoperative regimen will be defined statistically by using Student t-test and ANOVA for parametric data and U-test of Mann-Whitney for non-parametric data (p<0.05 will be taken as significant). Altogether, it is expected that such a multiplicity of signs and symptoms will give valuable data on specificities of Dry Eye after cataract surgery.
All the participant surgeons will have a summary document of the inclusion and exclusion criteria and a flowchart of the patient's enrollment process to improve compliance. The data will be stored on an external digital platform and only the data analyst will have access to it. In addition, there will be written records of each enrolled patient.
- Being tested
- The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)
- Keywords
- Cataract surgery, Dry eye disease, Ocular surface osmolarity, matrix metalloproteinase-9
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)Drug
All groups will receive a topical steroid-antibiotic for 3 weeks. The study groups will be also prescribed eye drops containing sodium hyaluronate 0.1% from the postoperative day 7 for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Control group. |
| Treatment 1 | Experimental | Sodium hyaluronate 0.1% eyedrops (Systane ultra plus), q.i.d from day 7 to day 30 after cataract surgery. Receives: Drug: The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod) |
| Treatment 2 | Experimental | Sodium hyaluronate 0.1% eyedrops (Hylo-comod), q.i.d from day 7 to day 30 after cataract surgery. Receives: Drug: The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry eye ocular symptoms
Difference in Ocular Surface Disease Index (OSDI) scores between groups.
Measured: Baseline, 30 days, 90 days
Secondary outcomes (3)
Non-invasive Break-up time
Difference in NIBUT scores between treated and untreated groups and between treated groups using 2 different lubricating drops.
Measured: Baseline, 30 days, 90 days
Tear osmolarity
Difference in Tear Osmolarity between treated and untreated groups and between treated groups using 2 different lubricating drops.
Measured: Baseline 30 days, 90 days
InflammaDry (MMP9) test
Difference in proportion of patients with a positive InflammaDry (MMP9) between treated and untreated groups and between treated groups using 2 different lubricating drops.
Measured: Baseline, 30 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be enrolled and randomly assigned by a computer generated randomization list in a 1:1:1 ratio to the intervention groups (2) or the control group. After cataract surgery, all groups will be given a topical steroid-antibiotic (tobramycin 0.3% and dexamethasone acetate 0.1%) commercially available and commonly used by ophthalmologists worldwide postoperatively, in a 3-week tapered regimen (every 2 hours the first day, then every 4 hours for 6 days, then 3 times a day for 1 week and twice a day for 1 week). The 2 study groups will be also prescribed lubricant eye drops from the postoperative day 7 containing sodium hyaluronate 0.1% (in 2 different commercially available formulations) to instill 4 times daily for the following 3 months. Study group patients will be instructed to instill the lubricant eyedrops at least 10 minutes after the tobramycin-dexamethasone eyedrops. At postoperative visits, patients will be asked about compliance with the assigned treatment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Oftalmológica Los Andes
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Luis Montecinos Buneder, MD, Principal investigator, Fundacion Oftalmologica Los AndesJuan Stoppel Ortiz, MD, Principal investigator, Fundacion Oftalmologica Los AndesFelipe Valenzuela Santana, MD, Study chair, Fundación Oftalmológica Los AndesCristobal Loezar Hernandez, MD, Principal investigator, Fundacion Oftalmologica Los Andes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711642
- Sponsor's protocol ID
- Dry Eye and Cataract Surgery
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Study on Dry Eye and Ocular Surface Disease Prior and After Cataract Surgery: Effects of Treatment on Dry Eye and Inflammatory Biomarkers.
- ClinicalTrials.gov ID
- NCT04711642
- Acronym / sponsor ID
- Dry Eye and Cataract Surgery
- Keywords
- Cataract surgery, Dry eye disease, Ocular surface osmolarity, matrix metalloproteinase-9
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación Oftalmológica Los AndesUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 15 Jan 2021 (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.
Ocular surface disease (OSD), particularly dry eye, is one of the most common conditions seen by ophthalmologists. Dry eye (DE) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear instability. DE significantly reduces quality of life and affects 5-30% of the population. As the proportion of individuals over age 60 increases because of greater life expectancies, we can anticipate the number of people with dry eye will also increase, which represents a major challenging for aging societies, like the Chilean one.
In the last few years clinical research on OSD is being intensely focused on diagnostic criteria, treatment strategies, methods used in diagnosis and better correlations between symptoms and clinical test results. All these lines of interest aim to improve the understanding of alterations and consequences occurring in the ocular surface disorders. Diagnostic testing is greatly valuable both for the detection of early changes due to DE and also to grade the severity of surface disease. The most commonly performed tests include the Schirmer test, tear break up time (TBUT), and ocular surface staining. However, newer point-of-care diagnostics tests such as tear osmolarity and matrix metalloprotease-9 (MMP-9) have been shown to have a high sensitivity and specificity in diagnosing ocular surface dysfunction.
Given that ocular surface dysfunction has been shown to have an adverse impact on visual function and can worsen after surgery, it is critical to identify and address any tear film and ocular surface abnormalities before cataract surgery. In the setting of preoperative cataract surgery planning, DE disease and meibomian gland dysfunction can impair critical refractive measures such as keratometry values worsening surgical outcomes.
To the best of our knowledge there are no ongoing or published studies that have evaluated DE and OSD as evidenced by either an abnormal tear-film parameter (elevated MMP-9 or abnormal osmolarity), or corneal surface and meibography evaluation findings (using novel non-invasive technology) in patients previous and after cataract surgery.
Detailed description
A prospective randomized study has been designed to assess and characterize OSD/DE in consecutive patients presenting for cataract surgery evaluation and to identify eventual changes on biomarkers of the tear film of the same population postoperatively. At the same time, 2 different postoperative eye drops regimen will be evaluated in order to determine its impact on postoperative OSD/DE.
All group of patients will be subjected to Dry Eye assessment using diagnosis criteria and methodologies recommended by the 2017 Dry Eye Workshop (DEWS II) (2), which includes the assessment of a battery of symptoms (OSDI questionnaire), signs (tear meniscus height, corneal and conjunctival lissamine green/fluorescein staining), laboratory tests (Schirmer I, TBUT assessment, tear osmolarity, tear MMP-9, meibography, ocular redness, lipid layer thickness) and physical examination (lid, meibum gland assessment). This assessment will be carried out in all groups preoperative and at postoperative week 4 and postoperative week 12.
Altogether, by identifying definite changes either in novel tear film biomarkers or non invasive ocular tests of patients subjected to cataract surgery, we expect to contribute to the understanding of the pathophysiology of the OSD and Dry Eye associated to cataract surgery and to give lights on the utility of those changes as biomarkers in diagnosis and therapy assessment in these conditions committing the ocular surface.
The research hypothesis is that there is a high prevalence of ocular surface dysfunction among patients presenting for cataract surgery as measured by point-of-care objective tear tests and cataract surgery results in altered ocular surface in a major fraction of patients. Dry eye symptoms are not necessary associated with objective signs in the ocular surface, but are less in the group of patients treated with associated lubricant eyedrops postoperatively. Patients more symptomatic in the postoperative period tend to have multiple preoperative OSD/DE biomarkers altered.
Consecutive patients presenting for cataract surgery evaluation will be recruited at the Fundacion Oftalmologica Los Andes (FOLA) Ophthalmology Clinic (Santiago, Chile). Patients will be eligible according to inclusion and exclusion criteria indicated. Eligible patients will be invited to participate voluntary in the study. The study will comprise three groups with 30-35 patients per group. Dry eye patients will be diagnosed according to TFOS DEWS II report and to the recommendations of the Dry Eye Workshop of 2017. It will basically consist of: a) patient history: symptoms and signs (e.g. ocular irritation, dryness or foreign body sensation, redness, etc), exacerbating conditions, duration of symptoms, etc., will be obtained by using the Ocular Surface Disease Index (OSDI). b) physical examination: visual acuity measurement, external examination and slit lamp biomicroscopy (tear film, tear meniscus, eyelashes, eyelid margins, conjunctiva, cornea, lens and retina). c) Diagnostic tests: Tear film osmolarity (using Tearlab), Tear film MMP-9 levels (using InflammaDry). Non-invasive tests will be performed using Keratograph 5M, which includes: non-invasive tear film break up time tear meniscus height, lipid layer thickness, ocular redness and meibography.
The study will comprise three groups. Each group will comprise 30-35 patients. Each of the 100 patients will be featured by a list of clinical parameters (ocular signs and symptoms and laboratory tests used conventionally for Dry Eye diagnostic). It is expected to observe differences in parameters before and after cataract surgery and between the control group and the two interventional groups. Association of those differences with the type of postoperative regimen will be defined statistically by using Student t-test and ANOVA for parametric data and U-test of Mann-Whitney for non-parametric data (p<0.05 will be taken as significant). Altogether, it is expected that such a multiplicity of signs and symptoms will give valuable data on specificities of Dry Eye after cataract surgery.
All the participant surgeons will have a summary document of the inclusion and exclusion criteria and a flowchart of the patient's enrollment process to improve compliance. The data will be stored on an external digital platform and only the data analyst will have access to it. In addition, there will be written records of each enrolled patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible patients will be enrolled and randomly assigned by a computer generated randomization list in a 1:1:1 ratio to the intervention groups (2) or the control group. After cataract surgery, all groups will be given a topical steroid-antibiotic (tobramycin 0.3% and dexamethasone acetate 0.1%) commercially available and commonly used by ophthalmologists worldwide postoperatively, in a 3-week tapered regimen (every 2 hours the first day, then every 4 hours for 6 days, then 3 times a day for 1 week and twice a day for 1 week). The 2 study groups will be also prescribed lubricant eye drops from the postoperative day 7 containing sodium hyaluronate 0.1% (in 2 different commercially available formulations) to instill 4 times daily for the following 3 months. Study group patients will be instructed to instill the lubricant eyedrops at least 10 minutes after the tobramycin-dexamethasone eyedrops. At postoperative visits, patients will be asked about compliance with the assigned treatment.
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Control group. |
| Treatment 1 | Experimental | Drug: The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)Sodium hyaluronate 0.1% eyedrops (Systane ultra plus), q.i.d from day 7 to day 30 after cataract surgery. |
| Treatment 2 | Experimental | Drug: The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)Sodium hyaluronate 0.1% eyedrops (Hylo-comod), q.i.d from day 7 to day 30 after cataract surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Indication of phacoemulsification for refractive purposes or for the presence of visually significant cataract.
- Absence of intraoperative or postoperative complications of phacoemulsification
- Willing to participate in the study (signed informed consent)
Key exclusion criteria (8 listed)
- Ocular surgeries within the previous 6 months.
- Contact lenses user.
- Severe blepharitis.
- Palpebral malposition and secondary dry eye
- History of filamentary keratitis, corneal neovascularization, or herpetic keratitis within previous 3 months.
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 |
|---|---|---|
| The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)All groups will receive a topical steroid-antibiotic for 3 weeks. The study groups will be also prescribed eye drops containing sodium hyaluronate 0.1% from the postoperative day 7 for 4 weeks. | Drug | Treatment 1, Treatment 2 |
Primary outcome
Dry eye ocular symptoms
Time frame: Baseline, 30 days, 90 days
Difference in Ocular Surface Disease Index (OSDI) scores between groups.
3 secondary outcomes
Non-invasive Break-up time
Time frame: Baseline, 30 days, 90 days
Tear osmolarity
Time frame: Baseline 30 days, 90 days
InflammaDry (MMP9) test
Time frame: Baseline, 30 days, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Luis Montecinos Buneder, MD principal investigator
Fundacion Oftalmologica Los Andes
Juan Stoppel Ortiz, MD principal investigator
Fundacion Oftalmologica Los Andes
Felipe Valenzuela Santana, MD study chair
Fundación Oftalmológica Los Andes
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod) in people with Dry Eye Disease and Dry Eye Syndrome, run by Fundación Oftalmológica Los Andes.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe Valenzuela Santana, MD (23704633, felipevalenz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry eye ocular symptoms (time frame: Baseline, 30 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2021.