Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dry Eye Syndromes
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum...
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
Tracking Information
- NCT #
- NCT04413253
- Collaborators
- Ocular Therapeutix, Inc.
- Investigators
- Not Provided
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