Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

Phase 1

Completed

• Conditions: Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
• Interventions: Drug: Cyclosporine 0.05% eye drops; Drug: Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%

• Registration Number: NCT05353101
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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.

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-04
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclosporine 0.05% eye drops group	Cyclosporine 0.05% eye drops	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.
Cyclosporine 0.05% eye drops group	Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%	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.

Primary Outcome Measures

Name	Time	Method
Changes of self-conscious symptoms	Day 0#7#15#30 and 60d	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.
Changes of ocular signs	Day 0#7#15#30 and 60d	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)

Trial Locations

Locations (1)

the Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China