UnknownNot Applicable

Temperature on Evaporative Dry Eye

China45 participantsStarted 2023-04-02

Plain-language 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. 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Non-invasive tear break-up time (NIBUT)

Timeframe: Day-0 (baseline), day-7, and day-14

Ocular Surface Disease Index (OSDI)

Timeframe: Day-0 (baseline), day-7, and day-14

Trial details

NCT IDNCT05720754

SponsorHe Eye Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

Contact for this trial

Emmanuel Eric Pazo, MD, PhD

0086-18612782131 ericpazo@outlook.com

View on ClinicalTrials.gov More Dry Eye trials