Visual fatigue
Conditions
Interventions
Control group:Vitamin B12 eye drops, 1 drop twice a day.
Experimental group:Vitamin B12 eye spray, 2 times a day, 1 spray each time.
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18-70 years (including boundary values); 2. The chief complaint was dryness, foreign body sensation, burning sensation, fatigue, discomfort, red eye, visual acuity fluctuation and other subjective symptoms. The score of Chinese Dry Eye Questionnaire was >7 points, 13 points <= ocular surface disease index (OSDI) score <=22 points; 3. Voluntarily participate in this clinical study, cooperate with all examinations and questionnaires included in the study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the ingredients in the test product or have contraindications. 2. Have used corticosteroids, cycloplegics, or antiallergic drugs within the past 3 months. 3. Patients with ophthalmic diseases such as keratitis, blepharitis, pterygium, cataract, fundus-related diseases, abnormalities of the eyelid surface, ocular malignancies, and a history of eye trauma: dry eye syndrome secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (such as vitamin A deficiency); 4. Congenital absence of lacrimal glands or meibomian glands in the eye; 5. Have undergone ocular surface surgery or intravitreal laser surgery with incisions within the past 6 months, or have plans to undergo any eye and/or eyelid surgery during the trial period; 6. According to the researchers' judgment, severe/critical ocular diseases, severe/critical systemic diseases, or uncontrolled medical conditions that may confound study evaluation or limit compliance; 7. Patients who have participated or are participating in other clinical trials within 1 month; 8. Subjects who are pregnant, breastfeeding, have a positive pregnancy test result, or plan to become pregnant; 9. Subjects who, in the opinion of the investigator, are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual fatigue scale score;Phase changes of ocular accommodation parameters before and after medication Change from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| After 7 and 14 days of treatment, the mean change of eye discomfort symptom score (VAS) from baseline was compared among the three groups;After 7 and 14 days of treatment, the asthenopia scale scores of the three groups were evaluated;After 7 and 14 days of treatment, the mean changes of corneal fluorescein staining scores from baseline in the three groups were compared;Evaluation of treatment satisfaction at 7 and 14 days of treatment;After 7 and 14 days of treatment, the mean change of tear film break-up time from baseline was compared among the three groups;After 7 and 14 days of treatment, the mean changes from baseline in the Schirmer tear test were compared among the three groups; | — |
Countries
China
Contacts
Public ContactXiong Ke
Southern Medical University Southern Hospital
Outcome results
None listed