Clinical trial NCT06975891: Performance of Systane PRO Versus Refresh Optive Mega-3
Official title: Subjective and Objective Performance of Systane PRO Versus Refresh Optive Mega-3 in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Scripps Poway Eyecare and Optometry
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2025-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Single site, prospective, double-masked, randomized-controlled, cross-over study of the subjective and objective performance of 2 different eyedrops. Subjects will be assessed at a screening visit, and 3 follow-up visits. Clinical evaluations will include patient questionnaires.


Eligibility criteria: Inclusion Criteria:

* Subjects who currently have moderate symptoms of dry eye as defined by a baseline OSDI score of 23-32 inclusive.
* Subjects between ages of 18-65 inclusive.
* Subjects who do not currently wear contact lenses.
* Subjects willing to fill out a daily diary during the duration of the study.
* Subjects willing to comply with the prescribed regimen and schedule of eye drops.
* Subjects willing to attend all study visits.

Exclusion Criteria:

* Have an ophthalmologic diagnosis of: allergy, viral or bacterial conjunctivitis, anterior blepharitis, parasitic infestations in any ocular structure or its adnexa, unresolved ocular trauma, ocular surface scarring diseases, corneal or conjunctival ulcers, filamentous keratitis, neurotrophic keratitis, bulous keratopathy, neoplastic diseases on the ocular surface or adnexa, diseases with fibrovascular proliferations on the conjunctival and/or corneal surface, retinal and/or posterior diseases that require treatment or threaten the visual prognosis, or glaucoma.
* Eyelid disorders that cause eyelid malposition, limit adequate eyelid closure or opening or cause epiphora.
* History of herpetic keratitis or ocular surgery.
* Have dry eye management that requires the implementation of any treatments (except artificial tears) of stage 2 of the recommendations in the treatment and management by stages for the dry eye disease of the TFOS DEWS I\| (Tear Film and Ocular Surface Society Dry Eye Workshop I).
* Have a history of drug addiction or drug dependence currently or within the last two years before signing the ICF.
* Have another medical condition, acute or chronic, that in the opinion of the investigator could increase the risk associated with participation in the study or the administration of the investigational product, or that could interfere with the interpretation of the results of the study.
* Pregnant or lactating.
* Current use of contact lenses.
* Have participated in another clinical research study ≤30 days before screening visit.
* Any use of eye drops, whether OTC or Rx, in last 14 days.
* Subjects who have previously used either investigational product in the past.
* Have known hypersensitivity to the components of the investigational product.

Primary outcomes:
measure: OSDI Questionnaire
timeFrame: Change from baseline to 28 days
Secondary outcomes:
measure: Visual Analog Score
timeFrame: Change from baseline to 28 days
Other outcomes:
measure: Likert Questionnaire
timeFrame: 28 days after start of eyedrop
measure: Eyedrop preference question
timeFrame: 28 days after start of second eyedrop
Locations:
city: San Diego
country: United States
facility: Scripps Poway Eyecare & Optometry
state: California
Study officials:
affiliation: Scripps Optometric Group
name: Jay Mashouf, OD
role: PRINCIPAL_INVESTIGATOR
References: