Performance of Systane PRO Versus Refresh Optive Mega-3

Launched by SCRIPPS POWAY EYECARE AND OPTOMETRY · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different eye drops, Systane PRO and Refresh Optive Mega-3, for treating dry eye symptoms. The goal is to see which eye drop works better in helping people feel more comfortable. The study is open to adults aged 18 to 65 who have moderate dry eye symptoms. To participate, you should not wear contact lenses and must be willing to keep a daily diary about your symptoms and attend several study visits.

If you join the study, you'll go through a screening visit and three follow-up visits where you'll answer questions about your symptoms and how the eye drops are working for you. It's important to note that there are certain conditions that could exclude you from participating, such as specific eye diseases or recent eye treatments. Overall, this trial aims to help improve options for people suffering from dry eye and contribute to better treatments in the future.

Gender

ALL

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.