> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Dry Eye Drugs
- URL: https://www.fdaweb.com/draft-guide-on-dry-eye-drugs/
- Published: 2020-12-18T12:00:00.000Z
- Updated: 2026-09-14T16:40:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148337

FDA has released a [draft guidance](https://www.fda.gov/media/144594/download?ref=fdaweb.com) entitled *Dry Eye: Developing* *Drugs for Treatment* that is intended to provide recommendations to sponsors about eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and greater efficiency in development programs for such drugs. It recommends both traditional environmental exposure trials and challenge-model trials (utilizing a controlled chamber with regulated temperature, air flow, humidity, etc.). The agency also recommends parallel, randomized by patient, double-masked trials in which the investigational drug group demonstrates superiority over the control group (control agent can be the vehicle). Additionally, the guidance recommends that safety trials be conducted at least six weeks in duration if efficacy trials are shorter in duration.