Dry EyeNCT05720754
Temperature on Evaporative Dry Eye
A study testing Diquafosol tetrasodium and Heated eye mask in people with Dry Eye, run by He Eye Hospital at 1 site in China.
Trial summary
Ocular surface temperature of a normal person is around 34.6 degree centigrade. After instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Diquafosol tetrasodium and Heated eye mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2023to 1 Aug 2023
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- The presence of at most one symptom including burning, foreign body sensation, itching or eye fatigue for 3 months
- OSDI score ≥ 13 and TBUT <5 s or NIBUT < 10s
- Able and willing to comply with the treatment/follow-up schedule
Who cannot join
- A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications
- Eyelids or intraocular tumors that should not put pressure
- Active allergy or infection or inflammatory disease that may have prevented the subjects from completing the study at the ocular surface
- Any structural change in lacrimal passage
- Glaucoma
- Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of ocular surface
- Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, antidepressive, and antihistamine medications within 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
He Eye Hospital
Shenyang, Liaoning, 110034
Emmanuel Eric Pazo, PhD, 0086-18612782131, ericpazo@outlook.com
Qin Guanghao, MD, 0086-18842664420, qinguanghao@hsyk.com.cn
About this study
Official title: Safety and Efficacy of Heated Artificial Tears Under Practical Conditions
Ocular surface temperature of a normal person is around 34.6 degree centigrade. After instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. Warm feeling will make blood vessels dilated and more blood will pass through to bring more blood flow out of our body to the heated area of the body and makes cells more permeable. Therefore, heating the ocular surface with heated eye mask after instilling artificial tears has the possibility to improve drug permeability on the ocular surface.
Read the detailed description
Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality, and reduced quality of life. 3% diquafosol (DQS) ophthalmic solution and heated eye mask (HEM) have been found to be beneficial in reducing signs and symptoms of dry eye. Warm compress therapy temperature of 40 °C to 45 °C have been typically advocated to melt the meibium causing obstruction at the orifices of the meibomian gland, eventually allowing increased lipid layer of the tear film. While in impact of heat on the ocular surface (OS) has not been extensively studied. Controlled and precise application of heat has the ability to create a cascade of events in the skin and thus aids in facilitating a faster movement of molecules into and across the skin. Possible mechanisms of enhancing drug permeation include on the ocular surface could be: (mechanisms may operate individually or concurrently):
- increase in drug diffusivity in the vehicle and/or in the ocular surface
- increase in partitioning and diffusion
- alteration in the lipid structure
- increased local blood flow Therefore, the purpose of this RCT is to assess the impact of instilling 3% DQS ophthalmic solution follow by HEM raising the OS temperature by 40 degrees centigrade for 10 minutes.
- Conditions
- Dry Eye
- Being tested
- Diquafosol tetrasodium, Heated eye mask
- Keywords
- dry eye, heated eye mask, diquafosol, tear breakup time, ocular surface disease index
- 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.
Diquafosol tetrasodiumDrug
Also called Diquas
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Heated eye maskDevice
Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms
| Study group | Role | What they receive |
|---|---|---|
| DQS+HEM | Experimental | Participants in the DQS+ group used DQS 1 drop 3 times/per day with heated eye mask for 2 weeks Receives: Drug: Diquafosol tetrasodium; Device: Heated eye mask |
| DQS | Active comparator | Participants in the DQS group used DQS 1 drop 3 times/per day for 2 weeks Receives: Drug: Diquafosol tetrasodium |
| HEM | Active comparator | Participants in the HEM group used heated eye mask 3 times/per day for 2 weeks Receives: Device: Heated eye mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear break-up time (NIBUT)
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-7, and day-14
Ocular Surface Disease Index (OSDI)
OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined
Measured: Day-0 (baseline), day-7, and day-14
Secondary outcomes (5)
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-7, and day-14
Meibomian gland function and secretion quality
Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum)
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-7, and day-14
Tear Film Lipid Layer Score (TFLL)
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-7, and day-14
Tear meniscus height (TMH)
Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-7, and day-14
Conjunctival hyperemia (RS score)
Conjunctival hyperemia (RS score) will be assessed by Keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 (normal) to 4.0 (severe).
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-7, and day-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start2 Apr 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Eric Pazo, MD, PhD, Study chair, He Eye Hospital, Shenyang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720754
- Sponsor's protocol ID
- EDEDQS2023
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.
Publications
Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5.
PubMed 32836200Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
PubMed 28736340Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 2004 Apr;2(2):149-65. doi: 10.1016/s1542-0124(12)70150-7.
PubMed 17216085Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S20-S26. doi: 10.1016/j.ophtha.2017.05.031.
PubMed 29055358Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
PubMed 28736335Kulkarni AA, Trousdale MD, Stevenson D, Gukasyan HJ, Shiue MH, Kim KJ, Read RW, Lee VH. Nucleotide-induced restoration of conjunctival chloride and fluid secretion in adenovirus type 5-infected pigmented rabbit eyes. J Pharmacol Exp Ther. 2003 Jun;305(3):1206-11. doi: 10.1124/jpet.103.049221. Epub 2003 Mar 20.
PubMed 12649304Dota A, Sakamoto A, Nagano T, Murakami T, Matsugi T. Effect of Diquafosol Ophthalmic Solution on Airflow-Induced Ocular Surface Disorder in Diabetic Rats. Clin Ophthalmol. 2020 Apr 1;14:1019-1024. doi: 10.2147/OPTH.S242764. eCollection 2020.
PubMed 32280196Jumblatt JE, Jumblatt MM. Regulation of ocular mucin secretion by P2Y2 nucleotide receptors in rabbit and human conjunctiva. Exp Eye Res. 1998 Sep;67(3):341-6. doi: 10.1006/exer.1998.0520.
PubMed 9778415Tanioka H, Kuriki Y, Sakamoto A, Katsuta O, Kawazu K, Nakamura M. Expression of the P2Y(2) receptor on the rat ocular surface during a 1-year rearing period. Jpn J Ophthalmol. 2014 Nov;58(6):515-21. doi: 10.1007/s10384-014-0342-4. Epub 2014 Sep 2.
PubMed 25179431Cowlen MS, Zhang VZ, Warnock L, Moyer CF, Peterson WM, Yerxa BR. Localization of ocular P2Y2 receptor gene expression by in situ hybridization. Exp Eye Res. 2003 Jul;77(1):77-84. doi: 10.1016/s0014-4835(03)00068-x.
PubMed 12823990
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Heated Artificial Tears Under Practical Conditions
- ClinicalTrials.gov ID
- NCT05720754
- Acronym / sponsor ID
- EDEDQS2023
- Conditions
- Dry Eye
- Keywords
- dry eye, heated eye mask, diquafosol, tear breakup time, ocular surface disease index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 2 Apr 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Feb 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.
Ocular surface temperature of a normal person is around 34.6 degree centigrade. After instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. Warm feeling will make blood vessels dilated and more blood will pass through to bring more blood flow out of our body to the heated area of the body and makes cells more permeable. Therefore, heating the ocular surface with heated eye mask after instilling artificial tears has the possibility to improve drug permeability on the ocular surface.
Detailed description
Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality, and reduced quality of life. 3% diquafosol (DQS) ophthalmic solution and heated eye mask (HEM) have been found to be beneficial in reducing signs and symptoms of dry eye. Warm compress therapy temperature of 40 °C to 45 °C have been typically advocated to melt the meibium causing obstruction at the orifices of the meibomian gland, eventually allowing increased lipid layer of the tear film. While in impact of heat on the ocular surface (OS) has not been extensively studied. Controlled and precise application of heat has the ability to create a cascade of events in the skin and thus aids in facilitating a faster movement of molecules into and across the skin. Possible mechanisms of enhancing drug permeation include on the ocular surface could be: (mechanisms may operate individually or concurrently):
- increase in drug diffusivity in the vehicle and/or in the ocular surface
- increase in partitioning and diffusion
- alteration in the lipid structure
- increased local blood flow Therefore, the purpose of this RCT is to assess the impact of instilling 3% DQS ophthalmic solution follow by HEM raising the OS temperature by 40 degrees centigrade for 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DQS+HEM | Experimental | Drug: Diquafosol tetrasodium, Device: Heated eye maskParticipants in the DQS+ group used DQS 1 drop 3 times/per day with heated eye mask for 2 weeks |
| DQS | Active comparator | Drug: Diquafosol tetrasodiumParticipants in the DQS group used DQS 1 drop 3 times/per day for 2 weeks |
| HEM | Active comparator | Device: Heated eye maskParticipants in the HEM group used heated eye mask 3 times/per day for 2 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- The presence of at most one symptom including burning, foreign body sensation, itching or eye fatigue for 3 months
- OSDI score ≥ 13 and TBUT <5 s or NIBUT < 10s
- Able and willing to comply with the treatment/follow-up schedule
Key exclusion criteria (7 listed)
- A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications
- Eyelids or intraocular tumors that should not put pressure
- Active allergy or infection or inflammatory disease that may have prevented the subjects from completing the study at the ocular surface
- Any structural change in lacrimal passage
- Glaucoma
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 |
|---|---|---|
| Diquafosol tetrasodiumAlso: Diquas3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms | Drug | DQS, DQS+HEM |
| Heated eye maskHeated eye mask will be used to assess its usefulness in dry eye signs and symptoms | Device | DQS+HEM, HEM |
Primary outcome
Non-invasive tear break-up time (NIBUT)
Time frame: Day-0 (baseline), day-7, and day-14
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. * Changes at day-14 and day-28 will be compare with baseline measurements. * Comparison between groups at baseline, day-14 and day-28 will also be examined.
Ocular Surface Disease Index (OSDI)
Time frame: Day-0 (baseline), day-7, and day-14
OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome. * Changes at day-14 and day-28 will be compare with baseline measurements. * Comparison between groups at baseline, day-14 and day-28 will also be examined
5 secondary outcomes
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Time frame: Day-0 (baseline), day-7, and day-14
Meibomian gland function and secretion quality
Time frame: Day-0 (baseline), day-7, and day-14
Tear Film Lipid Layer Score (TFLL)
Time frame: Day-0 (baseline), day-7, and day-14
Tear meniscus height (TMH)
Time frame: Day-0 (baseline), day-7, and day-14
Conjunctival hyperemia (RS score)
Time frame: Day-0 (baseline), day-7, and day-14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Results publication: PubMed 32836200Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5.
- Results publication: PubMed 28736340Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
- Results publication: PubMed 17216085Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 2004 Apr;2(2):149-65. doi: 10.1016/s1542-0124(12)70150-7.
- Results publication: PubMed 29055358Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S20-S26. doi: 10.1016/j.ophtha.2017.05.031.
- Results publication: PubMed 28736335Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
- Results publication: PubMed 12649304Kulkarni AA, Trousdale MD, Stevenson D, Gukasyan HJ, Shiue MH, Kim KJ, Read RW, Lee VH. Nucleotide-induced restoration of conjunctival chloride and fluid secretion in adenovirus type 5-infected pigmented rabbit eyes. J Pharmacol Exp Ther. 2003 Jun;305(3):1206-11. doi: 10.1124/jpet.103.049221. Epub 2003 Mar 20.
- Results publication: PubMed 32280196Dota A, Sakamoto A, Nagano T, Murakami T, Matsugi T. Effect of Diquafosol Ophthalmic Solution on Airflow-Induced Ocular Surface Disorder in Diabetic Rats. Clin Ophthalmol. 2020 Apr 1;14:1019-1024. doi: 10.2147/OPTH.S242764. eCollection 2020.
- Results publication: PubMed 9778415Jumblatt JE, Jumblatt MM. Regulation of ocular mucin secretion by P2Y2 nucleotide receptors in rabbit and human conjunctiva. Exp Eye Res. 1998 Sep;67(3):341-6. doi: 10.1006/exer.1998.0520.
- Results publication: PubMed 25179431Tanioka H, Kuriki Y, Sakamoto A, Katsuta O, Kawazu K, Nakamura M. Expression of the P2Y(2) receptor on the rat ocular surface during a 1-year rearing period. Jpn J Ophthalmol. 2014 Nov;58(6):515-21. doi: 10.1007/s10384-014-0342-4. Epub 2014 Sep 2.
- Results publication: PubMed 12823990Cowlen MS, Zhang VZ, Warnock L, Moyer CF, Peterson WM, Yerxa BR. Localization of ocular P2Y2 receptor gene expression by in situ hybridization. Exp Eye Res. 2003 Jul;77(1):77-84. doi: 10.1016/s0014-4835(03)00068-x.
- Individual participant dataSharing planned: Yes. The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.
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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.
Emmanuel Eric Pazo, MD, PhD study chair
He Eye Hospital, Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diquafosol tetrasodium and Heated eye mask in people with Dry Eye, run by He Eye 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 4 inclusion and 7 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 9 Feb 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.
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 Emmanuel Eric Pazo, MD, PhD (0086-18612782131, ericpazo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive tear break-up time (NIBUT) (time frame: Day-0 (baseline), day-7, and day-14). 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?
On the ClinicalTrials.gov record for NCT05720754, which also lists 10 linked publications.
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 9 Feb 2023; AzTrials last refreshed its copy on 27 Oct 2026.