CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Cyclosporine +2 moredrug
Likely dose
Dexamethasone 0.4 mg intracanalicular insert used in conjunction with cyclosporine ophthalmic emulsion; Loteprednol etabonate 0.5% ophthalmic suspension as alternative; cyclosporine monotherapy as controlAI-extracted
Key inclusion· 4
  • ✓Age 18 years or older
  • ✓Signs and symptoms of Dry Eye Disease
  • ✓Willing to be treated with topical immunomodulator
  • ✓Able and willing to comply with clinic visits and study procedures
Key exclusion· 9
  • ✕Under age 18
  • ✕Pregnancy (must be ruled out in women of childbearing potential)
  • ✕Active infectious systemic disease
  • ✕Active infectious ocular or extraocular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04555694
NCT04555694Phase 4Completed
CompareCT.gov

Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.

Thomas Chester, OD·interventional·Posted Sep 21, 2020·Updated Oct 11, 2023

In Brief

A Phase 4 clinical trial evaluating Cyclosporine, Loteprednol Etabonate, and 1 other intervention for Dry Eye. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedSep 21, 2020
Enrollment StartOct 1, 2020
Primary CompletionFeb 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.8 years ago

Interventions

Cyclosporinedrug

Used to increase tear production in patients who have dry eye caused by inflammation

Loteprednol Etabonatedrug

Used to treat inflammation of the eye

Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insertdrug

Used to treat inflammation of the eye