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Immunomodulator

Restasis and Lotemax for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by Thomas Chester, OD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4, week 8 and week 12
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4, week 8 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 4, week 8 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Ocular Surface Staining From Baseline
Secondary study objectives
DEQ-5 Score
Mean Conjunctival Staining
Mean Schirmer Tear Test 1 Score
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Restasis and LotemaxActive Control2 Interventions
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Group II: Restasis and DextenzaActive Control2 Interventions
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Group III: RestasisActive Control1 Intervention
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes

Find a Location

Who is running the clinical trial?

Thomas Chester, ODLead Sponsor
~6 spots leftby Nov 2025
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