Performance of Systane PRO Versus Refresh Optive Mega-3

Scripps Poway Eyecare and Optometry

Status and phase

Enrolling

Phase 4

Conditions

Dry Eye

Treatments

Drug: Refresh Optive MEGA-3

Drug: Systane PRO

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06975891

JM-25-01

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.