BL-RX01-TFSTAB-1402

NCT07790211 | Recruiting Phase 4 FDA Drug

• 1 other identifier: BL-RX01-TFSTAB-1402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Number of subjects with an increase from baseline of the Tear Film Index as assessed by the iTrace

  Compared from baseline to post-administration times at 5 minutes, 30 minutes, and 1 hour at both Visit One and Visit Two

Study Arms (1)

Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing Miebo

EXPERIMENTAL

Miebo administered once in each eye on Visit One and Visit Two

Drug: Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®

Interventions

Determine the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo® DRUG

Determine 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

Determine ability of iTrace™ BOSA™ OPD-Scan III & IDRA to detect tear film stability utilizing Miebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able and willing to follow instructions, including participation in all trial assessments and visits

You may not qualify if:

• Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters including:
• 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
• Abnormal cornea shape (keratoconus)
• Corneal epithelial defect or significant confluent staining or filaments
• History of ocular malignancy
• Pterygium in either eye
• Use of any of the following ocular therapies in the study eye within 24 hours prior to Visit 1 and Visit 2: Vuity®, VIZZ™, topical ocular steroid treatments, topical antibiotics, prescription dry eye therapy including varenicline nasal spray, over the counter dry eye therapy (such as artificial tears, re-wetting drops, or Lumify®), TrueTear™ device (intranasal tear neurostimulator), or topical anti-glaucoma medication
• Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
• Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye within 6 months prior to Visit 1
• Have worn contact lenses within 24 hours prior to Visit 1 and Visit 2.
• Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
• Female subjects who are pregnant, nursing, or planning a pregnancy

Sponsors & Collaborators

• Vance Thompson Vision: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Kayla Karpuk, OD

CONTACT

605-361-3937; kayla.karpuk@vancethompsonvision.com

Gabrielle Malmanger, CCRC, COA

CONTACT

elle.malmanger@vancethompsonvision.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (1)