Dry EyeNCT05748951
Evaluating a Device for Blocking the Tear Duct
A study testing Canalicular occlusion device in people with Dry Eye, run by AesculaTech, Inc. at 1 site in Mexico.
Trial summary
Participants will receive a tear duct plug to see if their eye comfort improves. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Canalicular occlusion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteMexico
- Study dates
- 7 Mar 2023to 22 Feb 2024
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 22 or older complaining of ocular dryness who report having to use artificial tears or lubricants.
- Both of the following conditions:
- Baseline symptoms score of 23 or higher on the OSDI questionnaire; and
- OSDI Questionnaire has 3 or fewer responses of "not applicable"
- Basal tear secretion (Schirmer I Test with anesthesia) < 10mm/5 minutes (in one of the two eyes). The eye with the lower score is the study eye.
- Willing and able to comply with the study procedures and follow-up.
- Willing and able to provide informed consent.
Who cannot join
- Presence or history of chronic or current, acute ocular inflammation or infection, aside from mild blepharitis or inflammation associated with primary dry eye or disorders which are known to cause dry eyes (e.g. Sjrögens Syndrome).
- The presence of any lacrimal occlusion, ocular disorder, or condition in either eye, conjunctiva, or lacrimal system that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., corneal transplant, routine ocular injections, recent ocular surgery, ectropion, surgical procedure such as cautery, or past canalicular surgery, significant corneal or conjunctival scarring, pterygium or nodular pinguecula; active ocular herpetic infection; lid or lacrimal cancer; clinically significant corneal dystrophy or other disorder which may cause rapid degeneration of visual acuity, such as anterior (epithelial) basement membrane corneal dystrophy, clinical keratoconus, or active, wet macular degeneration.
- Presence of - or unverified removal of - other canalicular occlusion devices.
- Chronic allergic rhinitis
- Allergic to study materials, supplies and medication.
- Contraindication to topical anesthesia.
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- Actively using a topical medication (such as steroids and immunosuppressants) for which the use of a plug may cause complications, regardless of dosage adjustment.
- Participation in another ophthalmic clinical trial within three months prior to enrollment. Participant must also be willing to refrain from another ophthalmic study for the duration of the study.
- Co-existing health condition(s), either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment, the compliance of the participant to the protocol, or other factors which may confound validity of study data collection or analysis. For example, participants who are pregnant or nursing, have pterygium, or uncontrolled blepharitis for which artificial lubricants do not provide relief are excluded. Unless post-menopausal or medically sterile (e.g hysterectomy, bilateral tubal ligation, bilateral oophorectomy), female participants must have a negative urine pregnancy test (UPT) on Day 0 of the study and should utilize a medically acceptable form of contraception over the course of the study.
- Use of drugs under any of the following conditions:
- Change in dry eye medication (e.g., Restasis or Xiidra) within 60 days prior to enrollment (i.e., participant drug use must be stable prior to the study. They may not be enrolled if they began drug use within the past 60 days of assessment or if they intend to begin prescription drug use during the study); or
- Systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial; or
- Oral tetracyclines or azithromycin between enrollment and 30 days prior, unless their dosage will remain the same throughout the study; or
- Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications between enrollment and 30 days prior to enrollment, with the exception that patients who are newly prescribed short-term use (15 days or less) anti-inflammatories (e.g., corticosteroids) by the investigator during their screening visit may be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Evaluation of Canalicular Occlusion
Participants will receive a tear duct plug to see if their eye comfort improves.
Read the detailed description
Participants will receive a canalicular occlusion and will be followed for 3 months so that safety and effectiveness of the device may be evaluated.
- Conditions
- Dry Eye
- Being tested
- Canalicular occlusion device
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canalicular occlusion deviceDevice
Occlusive device is inserted into the tear duct to block tear drainage
| Study group | Role | What they receive |
|---|---|---|
| Tear Duct Plug | Experimental | A device inserted into the tear duct to block tear drainage Receives: Device: Canalicular occlusion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in basal tear secretion (Schirmer I test, with anesthesia) for designated study eye from baseline to Week 12
Outcome reflects the volume of tears collected in the tear film over 5 minutes. A higher score reflects a larger tear film.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start7 Mar 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- AesculaTech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Amparo, MD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748951
- Sponsor's protocol ID
- TP-0183-01
- Status last verified
- Jul 2024
- First submitted
- 18 Feb 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Evaluation of Canalicular Occlusion
- ClinicalTrials.gov ID
- NCT05748951
- Acronym / sponsor ID
- TP-0183-01
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AesculaTech, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 1 Mar 2023 (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.
Participants will receive a tear duct plug to see if their eye comfort improves.
Detailed description
Participants will receive a canalicular occlusion and will be followed for 3 months so that safety and effectiveness of the device may be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tear Duct Plug | Experimental | Device: Canalicular occlusion deviceA device inserted into the tear duct to block tear drainage |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 22 or older complaining of ocular dryness who report having to use artificial tears or lubricants.
- Both of the following conditions:
- Basal tear secretion (Schirmer I Test with anesthesia) < 10mm/5 minutes (in one of the two eyes). The eye with the lower score is the study eye.
- Willing and able to comply with the study procedures and follow-up.
- Willing and able to provide informed consent.
Key exclusion criteria (14 listed)
- Presence or history of chronic or current, acute ocular inflammation or infection, aside from mild blepharitis or inflammation associated with primary dry eye or disorders which are known to cause dry eyes (e.g. Sjrögens Syndrome).
- The presence of any lacrimal occlusion, ocular disorder, or condition in either eye, conjunctiva, or lacrimal system that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., corneal transplant, routine ocular injections, recent ocular surgery, ectropion, surgical procedure such as cautery, or past canalicular surgery, significant corneal or conjunctival scarring, pterygium or nodular pinguecula; active ocular herpetic infection; lid or lacrimal cancer; clinically significant corneal dystrophy or other disorder which may cause rapid degeneration of visual acuity, such as anterior (epithelial) basement membrane corneal dystrophy, clinical keratoconus, or active, wet macular degeneration.
- Presence of - or unverified removal of - other canalicular occlusion devices.
- Chronic allergic rhinitis
- Allergic to study materials, supplies and medication.
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 |
|---|---|---|
| Canalicular occlusion deviceOcclusive device is inserted into the tear duct to block tear drainage | Device | Tear Duct Plug |
Primary outcome
Mean change in basal tear secretion (Schirmer I test, with anesthesia) for designated study eye from baseline to Week 12
Time frame: 3 months
Outcome reflects the volume of tears collected in the tear film over 5 minutes. A higher score reflects a larger tear film.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- 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.
Francisco Amparo, MD principal investigator
Independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canalicular occlusion device in people with Dry Eye, run by AesculaTech, Inc. 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 14 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: finished, as of the sponsor's last update on 30 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in basal tear secretion (Schirmer I test, with anesthesia) for designated study eye from baseline to Week 12 (time frame: 3 months). 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 30 Jul 2024.