allergic conjunctivitis
Conditions
Interventions
Olopatadine hydrochloride group:Olopatadine hydrochloride eye drops, 2 times a day, 1~2 drops/time, with an interval of more than 6-8 hours, for 2 weeks.
Combination drug group:According to the above two groups of drug regimens, olopatadine hydrochloride and Qinjiao granules were used at the same time.
Experimental group:Take Qinjiao granules 2 sachets 1 time after meals 2 times a day for 2 weeks.
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Understand and sign the informed consent form approved by the Ethics Committee; (2)Age 12~65 years old male or female; (3)Within 1 week prior to obtaining informed consent have any of the following signs of allergies:a)Positive blood or tear IgE antibody test b)Eosinophils are found on conjunctival scraping; (4)At the time of informed consent and baseline the following criteria should be met for eye itching:c)Itchy eye self-rating in either eye = 7 points. And the following signs: conjunctival injection conjunctival papilla cornea-specific lesion characteristics at least 1 investigator score = 1 point (all scores: 0~3 points). (5)TCM syndrome differentiation is a wind-heat syndrome. (6)Willing and able to comply with the examinations and observations specified in the trial protocol.
Exclusion criteria
Exclusion criteria: (1)Pregnant or lactating women. (2)Accompanied by ocular diseases other than allergic conjunctivitis that affect the efficacy and safety evaluation including but not limited to trauma requiring treatment drug-induced keratitis blepharitis follicular conjunctivitis dry eye glaucoma cornea iris anterior chamber active inflammation and/or substantial structural changes etc.; (3)The standard eye chart measures best-corrected visual acuity < 0.1 in either eye; (4)Weight < 35kg; (5)Concomitant active ocular infections (viral bacterial fungal protozoa) or a history of ocular herpes; (6)Concomitant retinal detachment diabetic retinopathy or any prior history of progressive retinal disease or with retinal disease that is likely to progress during the trial; (7)Have ocular disease other than allergic conjunctivitis that requires ocular topical treatment (including artificial tear preparations) during the trial period; (8)Require or plan to wear contact lenses (including orthokeratology lenses) for the duration of the t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change value of the maximum eye itch score from baseline in the 24 hours before the visit on the 15th day;The change in the score of bulbar conjunctival hyperemia compared with baseline at the visit on the 15th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| The maximum eye itch score within 24 hours before the visit on the 8th and 15th days, and the change value on the 8th day compared with baseline;;The maximum self rating of various eye symptoms (eye secretions, tears, and foreign body sensation) within 24 hours before the 8th and 15th day visits to the hospital, as well as the changes compared to baseline;The total investigator scores for eye signs (eyelid conjunctiva, conjunctiva (including conjunctival congestion), corneal margin, cornea) on the 8th and 15th day of hospital visits, as well as the changes compared to baseline;Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ scale);TCM Syndrome Scale;The bulbar conjunctival hyperemia score at the visit on day 8 and day 15, and the change value from baseline on day 8;;Eye exam;The sum of the maximum self ratings of eye symptoms (such as itching, eye discharge, tearing, and foreign body sensation) within 24 hours before the 8th and 15th day visits to the hospital, as well as the changes compared to baseline;On the 8th and 15th day of the hospital visit, the researcher's scores for various ocular signs (eyelid conjunctiva, conjunctiva (excluding conjunctival congestion), corneal margin, and cornea), as well as the changes compared to baseline, were evaluated; | — |
Countries
China
Contacts
Public ContactYanlin Zheng
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed