lipid deficiency dry eye
Conditions
Interventions
Research group:Sodium hyaluronate simulant, Ma Yinglong Babao eye ointment
Use sodium hyaluronate simulant in the morning, middle, and evening, 3 times a day, 1 drop each time
Use Ma Yinglong Babao Eye Cream at night, once a day, and apply it to the eyelids. Use both eyes continuously for 28 days.
control group:Sodium hyaluronate eye drops, Ma Yinglong Babao eye ointment simulator, use sodium hyaluronate eye drops in the morning, middle, and evening, 3 times a day, 1 drop each time
At night, use Ma Yinglong Babao eye ointment simulant once a day and apply it to the eyelids. Use both eyes continuously for 28 days.
Sponsors
Ophthalmic Hospital of Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent form the age range is between 18 and 65 years old (including 18 and 65 years old) and there is no gender restriction; 2. Before conducting any research related procedures a written informed consent form must be signed; 3. At the screening visit (first visit) the daily visual acuity of both eyes should be 4.5 or better on the standard logarithmic visual acuity chart(i.e. standard logarithmic visual acuity = 4.5); 4. Patients diagnosed with lipid deficiency according to the diagnostic criteria of the "Chinese Dry Eye Expert Consensus (2020 Edition)"; 5. Screening and baseline Schirmer I test for both eyes (without anesthesia) = 9mm; 6. The Modified Dry Eye Appearance Score (SANDE) for both the screening and baseline periods was = 40; 7. According to the researchers' assessment the anatomical structure of the eyelids is normal.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to any ingredients in Ma Yinglong Babao Eye Cream (artificial musk borax calcined calamine cinnabar borneol artificial bezoar pearls amber; excipients include Vaseline lanolin liquid paraffin); Or those who are allergic to sodium hyaluronate and its excipients; Or individuals with allergies who have been assessed by the researchers as unsuitable for participation in this trial; 2. Screening (Visit 1) for any relevant medication used for dry eye treatment within the past 30 days; 3. Any eye with a history of poorly controlled glaucoma an IOP exceeding 21 mmHg at the screening visit or any eye currently receiving eye drops for glaucoma treatment or having received glaucoma laser or surgical treatment in the study eye within 90 days prior to the study; 4. Individuals with a history of corneal epithelial malnutrition; 5. Individuals who have undergone corneal transplantation or similar corneal surgeries; 6. Have undergone any ocular surface incision surgery within the 6 months prior to screening including but not limited to corneal refractive surgery pterygium excision surgery etc; Or plan to undergo any eye surgery during the study period; 7. Have undergone eyelid surgery within the past 6 months; 8. Congenital complete absence of lacrimal gland or meibomian gland; 9. Burn the lacrimal punctum or insert or remove insoluble or short-term soluble lacrimal plugs (silicone or collagen) within 30 days prior to screening or planned during the study period; Received long-term soluble lacrimal punctum plug treatment within the 3 months prior to screening (Visit 1); 10. Has had active herpetic keratitis within the year prior to screening or is currently receiving long-term oral antiviral treatment for herpetic diseases; 11. A Meibomian gland diseases that have undergone mechanical meibomian gland unblocking treatment within the past 3 months. b. Excessive eyelid laxity eyelid laxity syndrome eyelid eversion eyelid inversion etc. c. There are conjunctival scars. d. Within one month after removing contact lenses. According to the researcher's assessment eye diseases that may interfere with the study evaluation or limit compliance; 12. Have a known history of drug dependence drug abuse or drug use within the past 5 years; 13. Patients who are unable to use the investigational drug as required; 14. Participants in other clinical trials within 3 months prior to the start of this trial; 15. Researchers believe that participants are not suitable for the trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the mean change in tear break-up time (BUT) between the study group and the control group compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the mean changes in VAS scores of eye discomfort symptoms (burning/stabbing sensation, itching, foreign body sensation, eye discomfort, photophobia, pain) between the study group and the control group compared to baseline;Mean change in ocular surface disease index (OSDI) scores between the comparative study group and the control group compared to baseline;Compare the mean changes in Schirmer Test (Schirmer I test no anesthesia SIT) between the study group and the control group compared to baseline;Compare the mean change in corneal fluorescein staining score (ICSS) between the study group and the control group compared to baseline; | — |
Countries
China
Contacts
Public Contactli ke xie
Ophthalmic Hospital of Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed