Comparing two types of eye drops for dry eye relief

Subjective and Objective Performance of Systane PRO Versus Refresh Optive Mega-3 in Dry Eye Patients

This study is testing which of two eye drops, Systane PRO or Refresh Optive Mega-3, works better to relieve dry eye symptoms in people who have moderate dryness.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Scripps Poway Eyecare and Optometry (other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06975891 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-site, prospective, double-masked, randomized-controlled, cross-over study designed to evaluate the performance of two different eye drops, Systane PRO and Refresh Optive Mega-3, in patients with moderate dry eye symptoms. Participants will undergo a screening visit followed by three follow-up visits where they will complete patient questionnaires and clinical evaluations. The study aims to assess both subjective and objective outcomes related to the effectiveness of the eye drops in alleviating dry eye symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who experience moderate dry eye symptoms and do not wear contact lenses.

Not a fit: Patients with specific ophthalmologic conditions or those who wear contact lenses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with more effective treatment options for managing dry eye symptoms.

How similar studies have performed: Other studies comparing different eye drop formulations have shown varying degrees of success, but this specific comparison is relatively novel.

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.

Where this trial is running

San Diego, California

• Scripps Poway Eyecare & Optometry — San Diego, California, United States (RECRUITING)

Study contacts

• Principal investigator: Jay Mashouf, OD — Scripps Optometric Group
• Study coordinator: Leslie Shan, OD

Conditions: Dry Eye