Contact Lens ComplicationNCT04663529
Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
An observational study of Contact Lens Complication and Dry Eye, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to analyze the changes of corneal nerve morphology and function in contact lens-related dry eye(CLADE) patients and further discuss the role of corneal nerve in the genesis and development of CLADE. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Complication, Dry Eye
- What is being tested?
- contact lens
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: DED patients from Peking University Third Hospital
Who may be able to join
- Age 18years to 40 years；
- Male or female DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without contact lens wear；
- Provision of written informed consent.
Who cannot join
- Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, ocular surgical history, laser treatment in the last 3 months, Meibomian function (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
- Pregnant and lactating women, or those planning a pregnancy over the course of the study
- Uncontrolled systemic disease
- Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
This study aims to analyze the changes of corneal nerve morphology and function in contact lens-related dry eye(CLADE) patients and further discuss the role of corneal nerve in the genesis and development of CLADE.
Read the detailed description
33 daily disposable soft contact lens wearers with dry eye disease(DED), 33 DED without contact lens wear and 33 normal control subjects will be involved in study. One experienced ophthalmologist will evaluate the DED symptoms and signs, which include ocular surface disease index(OSDI), tear film breakup time(TBUT), Schirmer Ⅰ test, corneal fluorescein staining, lissamine green staining and meibomian gland dropout rate. After evaluating, corneal sensitivity are measured using a Cochet-Bonnet aesthesiometer. Corneal nerve morphology will be assessed in the right eye using in vivo confocal microscopy(IVCM). Fifteen to twenty minutes after IVCM, 20μL of basal tears will be collected from the inferior meniscus of each participant to test tear neuropeptides. Then investigators analyse the correlation of corneal nerve changes and DED symptoms and signs.
- Conditions
- Contact Lens Complication, Dry Eye
- Being tested
- contact lens
- Keywords
- contact lens, tear film, dry eye, corneal sub-basal nerve
- 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.
contact lensOther
daily disposable soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| CLADE | contact lens wearers with DED Receives: Other: contact lens | |
| non-CLADE | DED without contact lens wear | |
| NC | normal control |
What is being measured
The primary outcome is the main question the study is designed to answer.
sub-basal corneal nerve density
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve fiber density will be calculated from a manual trace of the length of all nerve fibers in each 1 mm2 image.
Measured: baseline
sub-basal corneal nerve tortuosity
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve tortuosity will be assessed using a grading scale separately by two experienced ophthamologist.
Measured: baseline
Secondary outcomes (9)
ocular surface disease index(OSDI)
OSDI is one of the most frequently used questionnaires for evaluation of DED. This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Measured: baseline
Tear break-up time (TBUT)
TBUT is the time from normal blinking to the first appearance of a break in the tear film.
Measured: baseline
Schirmer Ⅰ test (SⅠt)
The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.
Measured: baseline
Corneal fluorescein staining
The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior).
Measured: baseline
Lissamine green staning
To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded.
Measured: baseline
meibomian gland droupout rate
meibomian gland evaluation
Measured: baseline
corneal sensitivity
Corneal sensitivity will be measured in the right eye only using the Cochet-Bonnet aesthesiometer and the ascending method of limits to determine the threshold of stimulus detection.
Measured: baseline
the concentration of substance P
20μL of basal tears will be collected from the inferior meniscus of each subject to test substance P. Substance P levels will be quantified by competitive enzyme-linked immunosorbent assays.
Measured: baseline
the concentration of CGRP
CGRP levels will be quantified by competitive enzyme-linked immunosorbent assays.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Oct 2020
- Primary completion1 May 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663529
- Sponsor's protocol ID
- CLADE
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT04663529
- Acronym / sponsor ID
- CLADE
- Conditions
- Contact Lens Complication, Dry Eye
- Keywords
- contact lens, tear film, dry eye, corneal sub-basal nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 11 Dec 2020 (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 aims to analyze the changes of corneal nerve morphology and function in contact lens-related dry eye(CLADE) patients and further discuss the role of corneal nerve in the genesis and development of CLADE.
Detailed description
33 daily disposable soft contact lens wearers with dry eye disease(DED), 33 DED without contact lens wear and 33 normal control subjects will be involved in study. One experienced ophthalmologist will evaluate the DED symptoms and signs, which include ocular surface disease index(OSDI), tear film breakup time(TBUT), Schirmer Ⅰ test, corneal fluorescein staining, lissamine green staining and meibomian gland dropout rate. After evaluating, corneal sensitivity are measured using a Cochet-Bonnet aesthesiometer. Corneal nerve morphology will be assessed in the right eye using in vivo confocal microscopy(IVCM). Fifteen to twenty minutes after IVCM, 20μL of basal tears will be collected from the inferior meniscus of each participant to test tear neuropeptides. Then investigators analyse the correlation of corneal nerve changes and DED symptoms and signs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CLADE | – | Other: contact lenscontact lens wearers with DED |
| non-CLADE | – | –DED without contact lens wear |
| NC | – | –normal control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- DED patients from Peking University Third Hospital
Key inclusion criteria (3 listed)
- Age 18years to 40 years；
- Male or female DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without contact lens wear；
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, ocular surgical history, laser treatment in the last 3 months, Meibomian function (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
- Pregnant and lactating women, or those planning a pregnancy over the course of the study
- Uncontrolled systemic disease
- Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
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 |
|---|---|---|
| contact lensdaily disposable soft contact lens | Other | CLADE |
Primary outcome
sub-basal corneal nerve density
Time frame: baseline
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve fiber density will be calculated from a manual trace of the length of all nerve fibers in each 1 mm2 image.
sub-basal corneal nerve tortuosity
Time frame: baseline
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve tortuosity will be assessed using a grading scale separately by two experienced ophthamologist.
9 secondary outcomes
ocular surface disease index(OSDI)
Time frame: baseline
Tear break-up time (TBUT)
Time frame: baseline
Schirmer Ⅰ test (SⅠt)
Time frame: baseline
Corneal fluorescein staining
Time frame: baseline
Lissamine green staning
Time frame: baseline
meibomian gland droupout rate
Time frame: baseline
corneal sensitivity
Time frame: baseline
the concentration of substance P
Time frame: baseline
the concentration of CGRP
Time frame: baseline
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 1 Jun 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contact Lens Complication and Dry Eye, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 4 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 1 Jun 2022. 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 China. 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?
sub-basal corneal nerve density (time frame: baseline). The study lists 2 primary outcomes in all. 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 1 Jun 2022.