Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

Nanchang University

Status and phase: Completed; Phase 1

Conditions: Cyclosporine 0.05% Eye Drops; Vernal Keratoconjunctivitis

Treatments: Drug: Cyclosporine 0.05% eye drops; Drug: Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%

Study type: Interventional

Funder types: Other

Identifiers

NCT05353101

[2020] No. (080)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Cyclosporine 0.05% eye drops group

Experimental group

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.

Treatment:

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

Drug: Cyclosporine 0.05% eye drops