Performance of Systane PRO Versus Refresh Optive Mega-3

Last updated: May 8, 2025
Sponsor: Scripps Poway Eyecare and Optometry
Overall Status: Active - Recruiting

Phase

4

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eyes

Treatment

Systane PRO

Refresh Optive MEGA-3

Clinical Study ID

NCT06975891
JM-25-01
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Subjects who currently have moderate symptoms of dry eye as defined by a baselineOSDI 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

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 conjunctivalulcers, filamentous keratitis, neurotrophic keratitis, bulous keratopathy,neoplastic diseases on the ocular surface or adnexa, diseases with fibrovascularproliferations on the conjunctival and/or corneal surface, retinal and/or posteriordiseases that require treatment or threaten the visual prognosis, or glaucoma.

  • Eyelid disorders that cause eyelid malposition, limit adequate eyelid closure oropening or cause epiphora.

  • History of herpetic keratitis or ocular surgery.

  • Have dry eye management that requires the implementation of any treatments (exceptartificial tears) of stage 2 of the recommendations in the treatment and managementby stages for the dry eye disease of the TFOS DEWS I| (Tear Film and Ocular SurfaceSociety Dry Eye Workshop I).

  • Have a history of drug addiction or drug dependence currently or within the last twoyears before signing the ICF.

  • Have another medical condition, acute or chronic, that in the opinion of theinvestigator could increase the risk associated with participation in the study orthe administration of the investigational product, or that could interfere with theinterpretation of the results of the study.

  • Pregnant or lactating.

  • Current use of contact lenses.

  • Have participated in another clinical research study ≤30 days before screeningvisit.

  • 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.

Study Design

Total Participants: 35
Treatment Group(s): 2
Primary Treatment: Systane PRO
Phase: 4
Study Start date:
June 01, 2025
Estimated Completion Date:
June 01, 2026

Connect with a study center

  • Scripps Poway Eyecare & Optometry

    San Diego, California 92131
    United States

    Active - Recruiting

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