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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05353101
Other study ID # [2020] No. (080)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 1, 2020
Est. completion date June 1, 2021

Study information

Verified date April 2021
Source Second Affiliated Hospital of Nanchang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Vernal keratoconjunctivitis (VKC) is an allergic disease that severely affects the eyesight of adolescents. Vernal keratoconjunctivitis (VKC) usually occurs in temperate regions such as the Mediterranean region, the Middle East, Africa, Central America, and the Indian subcontinent. In the EU an estimated 3.2 per 10,000 inhabitants (0.03%). It occurs repeatedly and mainly involves type I and type IV hypersensitivity. long-term standardized treatment is necessary. Therefore, this research aims to compare the readily available cyclosporine 0.05% eye drops and Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% in developing regions of Asia (China, Jiangxi Province) for long-term drug use in VKC patients in developing countries provide evidence.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Cyclosporine 0.05% eye drops
Use of 0.05% CSA could significantly reduce IL-4, IL-5, IL-17A, and TNF in tears of VKC patients- a? IFN- ? And eosinophil chemokine levels. Cyclosporine A (CSA) can effectively control ocular inflammation by blocking Th2 lymphocyte proliferation and IL-2 production. It can also inhibit the recruitment of eosinophils by inhibiting the release of histamine by mast cells and reducing the production of IL-5 further to improve its curative effect on VKC
Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
Corticosteroids can inhibit the release of mast cells, block the chemotaxis of inflammatory cells, and reduce the number of mast cells and eosinophils in the conjunctiva. At the same time, it can inhibit phospholipase A2 and quickly alleviate symptoms and signs.

Locations

Country Name City State
China the Second Affiliated Hospital of Nanchang University Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

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
See also
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Recruiting NCT02057822 - Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months N/A
Completed NCT03464435 - A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis Phase 4
Completed NCT00445120 - Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment Phase 2/Phase 3
Recruiting NCT03557203 - Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
Completed NCT01211327 - Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda Phase 4
Not yet recruiting NCT04705584 - Topical Immuonosuppressant Drugs in Spring Catarrh N/A
Completed NCT03379311 - A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis Phase 1
Completed NCT00426023 - Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis Phase 3
Completed NCT01751126 - Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis Phase 3
Recruiting NCT02456025 - Topical Tacrolimus in Vernal Keratoconjunctivitis Phase 4