Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

NCT05353101 | Completed Phase 1

• 1 other identifier: [2020] No. (080)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops

Keywords

Cyclosporine 0.05% eye drops; Vernal Keratoconjunctivitis; Immunomodulator; Olopatadine Hydrochloride Eye Drops

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Cyclosporine 0.05% eye drops group

EXPERIMENTAL

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; Drug: Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%

Interventions

Cyclosporine 0.05% eye drops DRUG

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

Cyclosporine 0.05% eye drops group

Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% DRUG

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.

Cyclosporine 0.05% eye drops group

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

the Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Cyclosporine; Ophthalmic Solutions; Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 29, 2022
• Study Start: July 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 29, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)