Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

Efficiency and Safety of Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis: a Non-randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
• Intervention / Treatment: Drug: Cyclosporine 0.05% eye drops; Drug: Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Cyclosporine 0.05% eye drops group; 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.

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- 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; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (ACTUAL): April 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Immunomodulator; Vernal Keratoconjunctivitis; Cyclosporine 0.05% eye drops; Olopatadine Hydrochloride Eye Drops
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Conjunctivitis, Allergic; Keratoconjunctivitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Anti-Bacterial Agents; Antifungal Agents; Anti-Allergic Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Loteprednol Etabonate; Ophthalmic Solutions; Tobramycin; Cyclosporine; Cyclosporins
• Other Study ID Numbers: [2020] No. (080)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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