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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two different eye drops, Systane PRO and Refresh Optive Mega-3, to determine which works better for people with moderate dry eye syndrome. Participants will use both eye drops in a specific order and provide feedback on their effectiveness. The trial is designed for individuals with moderate dry eye symptoms who do not wear contact lenses and are willing to attend all study visits. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits more patients.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop using any eye drops, whether over-the-counter or prescription, for at least 14 days before participating. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What is the safety track record for these treatments?

Studies have shown that both Systane PRO and Refresh Optive MEGA-3 are generally safe to use. Systane PRO may cause mild side effects such as a burning sensation, irritation, or redness in the eyes. Some individuals also experience watery eyes or blurred vision, but these effects are usually mild and resolve quickly.

Research indicates that Refresh Optive MEGA-3 is also well-tolerated. Like Systane PRO, it may cause mild burning, irritation, or redness. Blurred vision and watery eyes might occur as well, but they typically do not last long.

Both treatments are approved for relieving dry eyes and can be used as often as needed, demonstrating their safety. Always consult a doctor if any side effects feel severe or persist. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Systane PRO and Refresh Optive Mega-3 for dry eye syndrome because they offer unique formulations that could improve eye comfort. Unlike many standard treatments, Systane PRO has a specialized lipid-based formula that helps to stabilize the tear film and retain moisture on the eye surface. Refresh Optive Mega-3 stands out by incorporating flaxseed and castor oils, which are rich in omega-3 fatty acids, known for their anti-inflammatory properties. These features might provide enhanced relief and protection compared to traditional artificial tears, potentially offering faster and more lasting comfort for dry eye sufferers.

What evidence suggests that this trial's treatments could be effective for dry eye syndrome?

This trial will compare the effectiveness of Systane PRO and Refresh Optive MEGA-3 in treating dry eye syndrome. Studies have shown that both Systane PRO and Refresh Optive MEGA-3 effectively treat dry eye symptoms. Research indicates that Systane PRO significantly reduces dry eye signs and symptoms and improves quality of life, particularly for individuals who frequently use digital devices. Patients report feeling relief shortly after using these drops. Refresh Optive MEGA-3 also shows promise, as it contains flaxseed oil, which animal studies have shown to help reduce dry eye symptoms by improving eye health. Both eye drops have improved symptoms within a month of regular use. Participants in this trial will receive either Systane PRO followed by Refresh Optive MEGA-3 or vice versa. ^{4 6 7 8 9}

Who Is on the Research Team?

Jay Mashouf, OD

Principal Investigator

Scripps Optometric Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06439394

An Observational Study to Assess Optive MEGA-3 (OM3) ... This study will evaluate real-world experiences with Optive MEGA-3 (OM3) on relieving dry eye symptoms in adult participants with DED. OM3 is an over the ...

2. trialx.com trialx.com/clinical-trials/listings/298356/performance-of-systane-pro-versus-refresh-optive-mega-3/

Performance of Systane PRO Versus Refresh Optive Mega-3 Clinical trial for Dry Eye , Performance of Systane PRO Versus Refresh Optive Mega-3.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840372/

Artificial Tears: A Systematic Review - PMC There is good evidence that artificial tears improve symptoms of dry eye disease within a month of regular use, applied about four times a day.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06975891

Performance of Systane PRO Versus Refresh Optive Mega-3 Subjects are asked to rate how likely they would be to recommend these eyedrops for the treatment of dry eye symptoms: Very Unlikely, Somewhat Unlikely, Neither ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1542012419302733

An artificial tear containing flaxseed oil for treating dry eye ... In a mouse model of dry eye disease, the addition of flaxseed oil (short-chain omega-3 fatty acids) to hyaluronic acid eye drops reduced corneal epithelial ...

6. refresheyedrops.com refresheyedrops.com/95773.html

REFRESH OPTIVE MEGA-3® Lubricant Eye Drops REFRESH® products are safe to use as often as needed, so you can add them to your daily routine, or reach for REFRESH® when dry eye symptoms arise. Doctor ...

7. webmd.com webmd.com/drugs/2/drug-173715/refresh-optive-mega-3-pf-ophthalmic-eye/details

Refresh Optive Mega-3 (PF) Ophthalmic (Eye): Uses, Side ... Find patient medical information for Refresh Optive Mega-3 (PF) ophthalmic (eye) on WebMD including its uses, side effects and safety, interactions, ...

8. drugs.com drugs.com/mtm/refresh-optive-mega-3-preservative-free.html

Refresh Optive Mega-3 Preservative Free Refresh Optive Mega-3 Preservative Free side effects · mild eye burning or irritation; · itching or redness of your eyes; · watery eyes; · blurred ...

9. amazon.com amazon.com/Refresh-Optive-Mega-3-Lubricant-Flaxseed/dp/B078YGHYGY

Refresh Optive Mega-3 Lubricant Eye Drops with Flaxseed ... Long-Lasting Relief for Dry, Irritated Eyes – Specially formulated for those with Meibomian Gland Dysfunction (MGD). Lipid-Enhanced Formula – Features ...