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Evaluating a Device for Blocking the Tear Duct

Primary Purpose

Dry Eye

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Canalicular occlusion device
Sponsored by
AesculaTech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Sites / Locations

  • Córnea Atención EspecializadaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tear Duct Plug

Arm Description

A device inserted into the tear duct to block tear drainage

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2023
Last Updated
July 19, 2023
Sponsor
AesculaTech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05748951
Brief Title
Evaluating a Device for Blocking the Tear Duct
Official Title
A Pilot Clinical Evaluation of Canalicular Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
August 28, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AesculaTech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tear Duct Plug
Arm Type
Experimental
Arm Description
A device inserted into the tear duct to block tear drainage
Intervention Type
Device
Intervention Name(s)
Canalicular occlusion device
Intervention Description
Occlusive device is inserted into the tear duct to block tear drainage
Primary Outcome Measure Information:
Title
Mean change in basal tear secretion (Schirmer I test, with anesthesia) for designated study eye from baseline to Week 12
Description
Outcome reflects the volume of tears collected in the tear film over 5 minutes. A higher score reflects a larger tear film.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Amparo, MD
Phone
+52 33 3630 1372
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Amparo, MD
Organizational Affiliation
Independent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Córnea Atención Especializada
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Amparo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating a Device for Blocking the Tear Duct

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