Systane PRO vs Refresh Optive Mega-3 for Dry Eye Syndrome

Overseen By Leslie Shan, OD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Scripps Poway Eyecare and Optometry

Must not be taking: Eye drops

Disqualifiers: Glaucoma, Ocular surgery, Drug addiction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jay Mashouf, OD

Principal Investigator

Scripps Optometric Group

Eligibility Criteria

This trial is for individuals with Dry Eye Syndrome. Participants will be assessed at a screening visit and three follow-up visits. Details on specific inclusion or exclusion criteria are not provided, but typically these would cover age, severity of dry eye symptoms, and any other health conditions that might affect the outcome.

Inclusion Criteria

Subjects who do not currently wear contact lenses.

I am willing to keep a daily diary for the study.

I currently have moderate dry eye symptoms.

Exclusion Criteria

History of drug addiction or drug dependence currently or within the last two years before signing the ICF.

Have participated in another clinical research study ≤30 days before screening visit.

I have used eye drops in the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants receive Systane PRO or Refresh Optive Mega-3 eyedrops in a cross-over design

4 weeks

3 follow-up visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Refresh Optive MEGA-3
• Systane PRO

Trial Overview The study is testing the effectiveness of two different eyedrops: Refresh Optive MEGA-3 versus Systane PRO. It's a controlled experiment where patients use each product during separate periods to compare results based on their feedback and clinical evaluations.

Participant Groups

Group I: Systane PRO then Refresh Optive Mega-3 Experimental Treatment 2 Interventions

Group II: Refresh Optive Mega-3 then Systane PRO Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Scripps Poway Eyecare and Optometry

Lead Sponsor

Trials

2

Recruited

110+

Sengi

Industry Sponsor

Trials

28

Recruited

2,100+