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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

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
  • Dry Eye Syndrome
  • Sjögren's 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

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

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.

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,526 Total Patients Enrolled
Scott Hauswirth, ODStudy DirectorDompé Farmaceutici SpA
~109 spots leftby Feb 2025