Clinical trial

Safety and Efficacy of Heated Artificial Tears Under Practical Conditions

Name
EDEDQS2023
Description
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.
Trial arms
Trial start
2023-04-02
Estimated PCD
2023-07-01
Trial end
2023-08-01
Status
Not yet recruiting
Treatment
Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Arms:
DQS, DQS+HEM
Other names:
Diquas
Heated eye mask
Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms
Arms:
DQS+HEM, HEM
Size
45
Primary endpoint
Non-invasive tear break-up time (NIBUT)
Day-0 (baseline), day-7, and day-14
Ocular Surface Disease Index (OSDI)
Day-0 (baseline), day-7, and day-14
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the three groups.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2023-02-09

1 organization

1 product

1 indication

Organization
He Eye Hospital
Product
Diquafosol
Indication
Dry Eye