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New treatment option for Dry Eye Disease (DED)
Official title The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
ClinicalTrials.gov ID: NCT06655441
What this study is testing
What is 3% trehalose?
3% trehalose is an investigational medicine, being studied as a potential treatment for dry eye disease (ded).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to evaluate the effects of trehalose, an ingredient found in commercially available artificial tears, on the corneal barrier function. The investigators will assess corneal dryness and measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of sodium fluorescein dye into the eye) after using eye drops that contain 3% trehalose for one month.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult people, \> age 18 years, with moderate-to-severe dry eye, defined as fitting criteria for dry eye stages 3 or 4 of the MGD Workshop Management...
- people must have normal eyelid position and closure.
- For enrollment as aqueous tear deficiency, people must have a Schirmer I result of \< 5.0 mm wetting in 5 minutes without anesthesia.
You likely can't join if
- History or evidence of ocular or intraocular surgery in either eye within the past twelve months. LASIK and other kerato-refractive procedure...
- History or evidence of serious ocular trauma in either eye within the past six months.
- History of hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea...
- History or evidence of active ocular allergy.
- Females who are pregnant, nursing, or planning a pregnancy during the study.
See the full eligibility criteria
- Adult people, \> age 18 years, with moderate-to-severe dry eye, defined as fitting criteria for dry eye stages 3 or 4 of the MGD Workshop Management and Treatment subcommittee report.
- people must have normal eyelid position and closure.
- For enrollment as aqueous tear deficiency, people must have a Schirmer I result of \< 5.0 mm wetting in 5 minutes without anesthesia.
- History or evidence of ocular or intraocular surgery in either eye within the past twelve months. LASIK and other kerato-refractive procedure patients can qualify if the most recent surgery or enhancement was 12 or more...
- History or evidence of serious ocular trauma in either eye within the past six months.
- History of hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or...
- History or evidence of active ocular allergy.
- Females who are pregnant, nursing, or planning a pregnancy during the study.
- Evidence of greater than mild eyelid deformity (e.g., ectropion, entropion, ptosis).
- Use of concomitant topical ocular medications during the study duration.
- Individuals using systemic steroids, immunosuppressive agents and/or anti-cholinergic (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be...
- Individuals with uncontrolled diabetes or history or evidence of peripheral neuropathy.
- Active intraocular inflammatory conditions such as iritis.
- Individuals wearing rigid gas permeable or scleral contact lenses within the previous six months of enrollment. people can have worn soft lenses, but not within one month prior to enrollment.
- Individuals using punctual plugs inserted within 30 days of study start.
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.