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Full Analysis set for Dry Eye Syndrome (GEMINAE Trial)

N/A
Recruiting
Research Sponsored by Dompé Farmaceutici S.p.A
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 visit 1 (day 1)
Awards & highlights
No Placebo-Only Group

Summary

Primary Objective - To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity. Secondary Objectives * To assess corneal sensitivity via Cochet-Bonnet esthesiometer. * To assess tear secretion via Schirmer I test. * To assess OPAS questionnaire results.

Eligible Conditions
  • Sjögren's Syndrome
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity
Secondary study objectives
Corneal sensitivity, as measured via Cochet-Bonnet esthesiometer.
OPAS questionnaire results.
Tear secretion, as measured via Schirmer I test.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Full Analysis setExperimental Treatment1 Intervention
The full analysis set includes all patients who meet all the inclusion criteria and none of the exclusion criteria at the end of the screening procedure. All the analyses on the primary and secondary endpoints will be provided on this population. The screened population consists of all patients who sign the ICF and are assigned a patient identification number. Please note that the sample size may vary depending on feasibility.

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Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,513 Total Patients Enrolled
Scott Hauswirth, ODStudy DirectorDompé Farmaceutici SpA
~68 spots leftby Feb 2025
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