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Dry Eye Disease for Dry Eye Syndrome (COAT Trial)
Phase 4
Waitlist Available
Led By John Hovanesian, MD
Research Sponsored by Research Insight LLC
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 after 7, 14, 28 days of treatment
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 7, 14, 28 days of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 7, 14, 28 days of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in corneal high order aberrations (HOA)
Secondary study objectives
Change in corneal staining
Other study objectives
Change in best corrected visual acuity
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dry Eye DiseaseExperimental Treatment1 Intervention
Patient with dry eye disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclosporine ophthalmic solution
2013
Completed Phase 4
~230
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Who is running the clinical trial?
Research Insight LLCLead Sponsor
12 Previous Clinical Trials
843 Total Patients Enrolled
John Hovanesian, MDPrincipal InvestigatorHarvard Eye Associates
13 Previous Clinical Trials
4,483 Total Patients Enrolled
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