Performance of Systane PRO Versus Refresh Optive Mega-3

NCT06975891 | Terminated Phase 4 FDA Drug

• 1 other identifier: JM-25-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• OSDI Questionnaire

  The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.

  Change from baseline to 28 days

Secondary Outcomes (1)

• Visual Analog Score

  Change from baseline to 28 days

Other Outcomes (2)

• Likert Questionnaire

  28 days after start of eyedrop

• Eyedrop preference question

  28 days after start of second eyedrop

Study Arms (2)

Systane PRO then Refresh Optive Mega-3

OTHER

Drug: Systane PRO; Drug: Refresh Optive MEGA-3

Refresh Optive Mega-3 then Systane PRO

OTHER

Drug: Systane PRO; Drug: Refresh Optive MEGA-3

Interventions

Refresh Optive MEGA-3 DRUG

Lubricating Eyedrops

Refresh Optive Mega-3 then Systane PRO; Systane PRO then Refresh Optive Mega-3

Systane PRO DRUG

Lubricating Eyedrops

Refresh Optive Mega-3 then Systane PRO; Systane PRO then Refresh Optive Mega-3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Poway Eyecare and Optometry: lead
• Sengi: collaborator

Study Sites (1)

Scripps Poway Eyecare & Optometry

San Diego, California, 92131, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jay Mashouf, OD

  Scripps Optometric Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)