Dry EyePhase 4NCT06043908
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
A Phase 4 study testing artificial tear eyedrops and 0.05% cyclosporine eyedrops in people with Dry Eye, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- artificial tear eyedrops and 0.05% cyclosporine eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2022to 31 Dec 2023
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old.
- Any gender.
- Provision of written informed consent.
Who cannot join
- active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
- 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, 1 recruiting
- Recruiting
Hong Qi
Beijing, Beijing Municipality, 100191
Hong Qi, M.D., 13901066889, doctorqihong@163.com
Lu Zhao, M.D., +8619801152870, Drzl1996@163.com
About this study
Official title: The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye
The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.
Read the detailed description
The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. At the same time, this study further observed whether 0.05% cyclosporine eyedrops combined with artificial tear eyedrops were more beneficial to ocular surface repair and tear film homeostasis compared with traditional artificial tears alone.
- Conditions
- Dry Eye
- Being tested
- artificial tear eyedrops, 0.05% cyclosporine eyedrops
- Keywords
- dry eye, refractive surgery, 0.05% cyclosporine
- 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.
artificial tear eyedropsDrug
The intervention group and control group were treated with artificial tear eyedrops four times a day.
0.05% cyclosporine eyedropsDrug
The intervention group was treated twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 0.05% cyclosporine eyedrops combined with artificial tear eyedrops | Experimental | 0.05% cyclosporine eyedrops combined with artificial tear eyedrops Receives: Drug: artificial tear eyedrops; Drug: 0.05% cyclosporine eyedrops |
| artificial tear eyedrops | Active comparator | artificial tear eyedrops Receives: Drug: artificial tear eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular surface disease index (OSDI)
OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Measured: from baseline to 3 months after treatment
Tear break-up time (TBUT)(s)
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Measured: from baseline to 3 months after treatment
Corneal fluorescein staining (CFS)
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). The scores range from 0 to 15.
Measured: from baseline to 3 months after treatment
Schirmer I test (SIt) (mm/5 minutes)
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: from baseline to 3 months after treatment
Lissamine green staining
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: from baseline to 3 months after treatment
Secondary outcomes (17)
the concentration of Interleukin-1β (IL-1β) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-1β levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of Interleukin-6 (IL-6) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-6 levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of Interleukin-10 (IL-10) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-10 levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of Interleukin-23 (IL-23) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-23 levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of Interleukin-17A (IL-17A) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IL-17A levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. TNF-α levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of interferon-γ (IFN-γ)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. IFN-γ levels will be quantified by Luminex immunoassay
Measured: from baseline to 3 months after treatment
the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this inflammatory cytokine. GM-CSF levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of substance P (SP)(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. SP levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. α-MSH levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of β-endorphin (pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. β-endorphin levels will be quantified by Luminex immunoassay
Measured: from baseline to 3 months after treatment
the concentration of neurotensin (pg/ml
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. β-endorphin levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
the concentration of oxytocin(pg/ml)
basal tears will be collected from the inferior meniscus of each subject to test this neuropeptide. oxytocin levels will be quantified by Luminex immunoassay.
Measured: from baseline to 3 months after treatment
corneal sensitivity (range, 60-0 mm)
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: from baseline to 3 months after treatment
sub-basal corneal nerve density (mm/mm2)
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope.
Measured: from baseline to 3 months after treatment
numerical rating scale (NRS)
The NRS was used to evaluate ocular pain and consists of a numbered line from 0 to 10 scores that measures pain intensity: 0-1: no pain; 2-4: mild pain; 5-7: moderate pain; and 8-10: severe pain.
Measured: from baseline to 3 months after treatment
NPSI-Eye (range 0-100 score)
Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period)
Measured: from baseline to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043908
- Sponsor's protocol ID
- RS01
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao L, Chen J, Duan H, Yang T, Ma B, Zhou Y, Bian L, Cai X, Qi H. Efficacy of topical 0.05% cyclosporine A and 0.1% sodium hyaluronate in post-refractive surgery chronic dry eye patients with ocular pain. BMC Ophthalmol. 2024 Jan 22;24(1):28. doi: 10.1186/s12886-024-03294-z.
PubMed 38247010
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye
- ClinicalTrials.gov ID
- NCT06043908
- Acronym / sponsor ID
- RS01
- Conditions
- Dry Eye
- Keywords
- dry eye, refractive surgery, 0.05% cyclosporine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Sep 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.
The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.
Detailed description
The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. At the same time, this study further observed whether 0.05% cyclosporine eyedrops combined with artificial tear eyedrops were more beneficial to ocular surface repair and tear film homeostasis compared with traditional artificial tears alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.05% cyclosporine eyedrops combined with artificial tear eyedrops | Experimental | Drug: artificial tear eyedrops, Drug: 0.05% cyclosporine eyedrops0.05% cyclosporine eyedrops combined with artificial tear eyedrops |
| artificial tear eyedrops | Active comparator | Drug: artificial tear eyedropsartificial tear eyedrops |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old.
- Any gender.
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
- 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 |
|---|---|---|
| artificial tear eyedropsThe intervention group and control group were treated with artificial tear eyedrops four times a day. | Drug | 0.05% cyclosporine eyedrops combined with artificial tear eyedrops, artificial tear eyedrops |
| 0.05% cyclosporine eyedropsThe intervention group was treated twice a day. | Drug | 0.05% cyclosporine eyedrops combined with artificial tear eyedrops |
Primary outcome
ocular surface disease index (OSDI)
Time frame: from baseline to 3 months after treatment
OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Tear break-up time (TBUT)(s)
Time frame: from baseline to 3 months after treatment
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Corneal fluorescein staining (CFS)
Time frame: from baseline to 3 months after treatment
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). The scores range from 0 to 15.
Schirmer I test (SIt) (mm/5 minutes)
Time frame: from baseline to 3 months after treatment
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.
Lissamine green staining
Time frame: from baseline to 3 months after treatment
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.
17 secondary outcomes
the concentration of Interleukin-1β (IL-1β) (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-6 (IL-6) (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-10 (IL-10) (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-23 (IL-23) (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of Interleukin-17A (IL-17A) (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of interferon-γ (IFN-γ)(pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of substance P (SP)(pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of β-endorphin (pg/ml)
Time frame: from baseline to 3 months after treatment
the concentration of neurotensin (pg/ml
Time frame: from baseline to 3 months after treatment
the concentration of oxytocin(pg/ml)
Time frame: from baseline to 3 months after treatment
corneal sensitivity (range, 60-0 mm)
Time frame: from baseline to 3 months after treatment
sub-basal corneal nerve density (mm/mm2)
Time frame: from baseline to 3 months after treatment
numerical rating scale (NRS)
Time frame: from baseline to 3 months after treatment
NPSI-Eye (range 0-100 score)
Time frame: from baseline to 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 38247010Zhao L, Chen J, Duan H, Yang T, Ma B, Zhou Y, Bian L, Cai X, Qi H. Efficacy of topical 0.05% cyclosporine A and 0.1% sodium hyaluronate in post-refractive surgery chronic dry eye patients with ocular pain. BMC Ophthalmol. 2024 Jan 22;24(1):28. doi: 10.1186/s12886-024-03294-z.
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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.
Hong Qi principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing artificial tear eyedrops and 0.05% cyclosporine eyedrops in people with 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hong Zhao (13901066889 ext. 010, doctorqihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular surface disease index (OSDI) (time frame: from baseline to 3 months after treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06043908, which also lists 1 linked publication.
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 21 Sep 2023.