Vernal Keratoconjunctivitis Clinical Trial
Official title:
Efficiency and Safety of Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis: a Non-randomized Controlled Study
Verified date | April 2021 |
Source | Second Affiliated Hospital of Nanchang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To observe and compare the clinical efficacy of cyclosporine 0.05% eye drops with Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% in the treatment of Vernal Keratoconjunctivitis in developing regions of China.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility | Inclusion criteria - patients had a noticeable seasonal, and recurrent Itching, Discomfort(burning, stinging, and foreign body sensation), Photophobia and tears, Viscous discharge; - Slit-lamp microscopy showed Conjunctival Hyperemia, Tarsal papillary, Limbal hypertrophy, Horner-Trantas dots, Keratitis in some patients; - No other medication history in recent 2 weeks; - Patients have high compliance and are willing to take drugs on time and return to the clinic in time Exclusion criteria: - with other related immune diseases or other drug use history in recent 2 weeks; - Patients with evident and severe organic diseases or mental diseases; - Low compliance, unable to take drugs on time or fail to return to the clinic on time. |
Country | Name | City | State |
---|---|---|---|
China | the Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital of Nanchang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of ocular signs | The eye signs of the patients were observed under a slit lamp, including Conjunctival Hyperemia, Tarsal papillary, Limbal hypertrophy, Horner-Trantas dots, and Keratitis in some patients.The observer gives the corresponding score.The higher the score, the more serious it is (0-4 points) | Day 0#7#15#30 and 60d | |
Primary | Changes of self-conscious symptoms | The VAS scoring table was used for the patients' self-conscious symptoms, including pruritus, foreign body sensation, Photophobia and tears, and viscous secretions. The patients under study were self-scored at each review. 0-100 points, 0 indicates no discomfort, and 100 indicates the most significant pain. The intraocular pressure at each review was recorded by a non-contact tonometer. | Day 0#7#15#30 and 60d |
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