BL-RX01-TFSTAB-1402
ConditionDry Eye
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVance Thompson Vision
About this trial
A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 18 years of age at the time of consent
Able to provide written voluntary informed consent
Must have a normal pre-corneal tear film in one or both eyes[MC4.1][AA4.2]
Subjects cannot have instilled any topical ocular drops (including OTC lubricant drops) within 24 hours of Visit 1 and Visit 2.
Disqualifiers
History of Stevens-Johnson syndrome
Active blepharitis or lid margin inflammation
DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
Abnormal lid anatomy causing incomplete eyelid closure
Trial design
Design model
Single group
Treatments tested in this trial
Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®
DrugDetermine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® by examining potential differences in various tear film assessments before dosing Miebo® and at multiple timepoints post-Miebo® dosing
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing MieboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of subjects with an increase from baseline of the Tear Film Index as assessed by the iTrace
Time frame
Compared from baseline to post-administration times at 5 minutes, 30 minutes, and 1 hour at both Visit One and Visit TwoSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vance Thompson Vision
Lead sponsor
Bausch & Lomb Incorporated
Collaborator
Source ClinicalTrials.gov