Back to resultsCyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial
Primary Purpose
Vernal Keratoconjunctivitis, Cyclosporine 0.05% Eye Drops
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cyclosporine 0.05% eye drops
Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
Sponsored by
About this trial
This is an interventional treatment trial for Vernal Keratoconjunctivitis focused on measuring Cyclosporine 0.05% eye drops, Vernal Keratoconjunctivitis, Immunomodulator, Olopatadine Hydrochloride Eye Drops
Eligibility Criteria
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.
Sites / Locations
- the Second Affiliated Hospital of Nanchang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cyclosporine 0.05% eye drops group
Arm Description
The patients with VKC will receive Cyclosporine 0.05% eye drops or Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% effect of Cyclosporine 0.05% eye drops would be evaluated during the follow-up visits.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05353101
First Posted
April 24, 2022
Last Updated
April 28, 2022
Sponsor
Second Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT05353101
Brief Title
Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial
Official Title
Efficiency and Safety of Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis: a Non-randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vernal Keratoconjunctivitis, Cyclosporine 0.05% Eye Drops
Keywords
Cyclosporine 0.05% eye drops, Vernal Keratoconjunctivitis, Immunomodulator, Olopatadine Hydrochloride Eye Drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyclosporine 0.05% eye drops group
Arm Type
Experimental
Arm Description
The patients with VKC will receive Cyclosporine 0.05% eye drops or Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% effect of Cyclosporine 0.05% eye drops would be evaluated during the follow-up visits.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine 0.05% eye drops
Intervention Description
Use of 0.05% CSA could significantly reduce IL-4, IL-5, IL-17A, and TNF in tears of VKC patients- α、 IFN- γ 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
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of ocular signs
Description
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)
Time Frame
Day 0#7#15#30 and 60d
Title
Changes of self-conscious symptoms
Description
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.
Time Frame
Day 0#7#15#30 and 60d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
the Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial
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