Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT06942793
Brief Summary:
This is a phase III, multicenter, randomized, double-masked, Active-controlled design. The aims to confirm previous findings of the efficacy and safety of CsA-PG Ophthalmic Gel by comparing it to CsA Ophthalmic Gel for treating dry eye symptoms.
Detailed Description:
396 subjects will be enrolled (198 in each treatment group). Subject selection will be conducted during a 14-day run-in period before randomization. After the screening, subjects will receive lubricant eye drops (Refresh Tears®, Carboxymethylcellulose Sodium (0.5%)) treatment bilaterally BID for 14 days. Eligible subjects will be randomized (1:1) and receive the experimental drug or control drug , administered bilaterally once daily for 84 days.
Study:
NCT06942793
Study Brief:
Protocol Section:
NCT06942793