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:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT03764735
Brief Summary:
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Detailed Description:
Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).
The Primary Endpoints are:
Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;
Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom
Study:
NCT03764735
Study Brief:
Protocol Section:
NCT03764735