Eye Drops for Dry Eye Syndrome

(PreDICT Trial)

Overseen By Nancy Gee, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Tufts Medical Center

Must not be taking: Topical treatments

Disqualifiers: Centralized pain, Ocular surgery, 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: 2

Duration: 4 weeks

66 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will undergo Dry Eye Disease testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the Dry Eye Disease tests and functional nerve tests will be repeated.

Will I have to stop taking my current medications?

The trial requires that you have not changed your medications in the last 3 months and do not anticipate any changes during the study. If you are using other topical treatments, you may need to stop them.

What data supports the effectiveness of the treatment Preservative-free Refresh Optive Advanced Lubricant Eye Drops for Dry Eye Syndrome?

Research shows that lipid-based lubricant eye drops, like those in Refresh Optive Advanced, are effective in managing dry eye symptoms, especially in conditions where the eye's natural lipid layer is deficient. ^{1 2 3 4 5}

Is Preservative-free Refresh Optive Advanced Lubricant Eye Drops safe for use?

Research suggests that Optive eye drops may cause some irritation and damage to the eye surface over time, likely due to its preservative. However, more clinical data is needed to understand how often this might happen in real-world use. ^{3 6 7 8 9}

How is Preservative-free Refresh Optive Advanced Lubricant Eye Drops different from other treatments for dry eye syndrome?

Preservative-free Refresh Optive Advanced Lubricant Eye Drops are unique because they do not contain preservatives, which can be irritating for some people with dry eyes. This makes them a gentler option compared to other eye drops that may contain preservatives. ^{6 8 10 11 12}

Research Team

Stephanie Cox, OD

Principal Investigator

Tufts Medical Center New England Eye Center

Eligibility Criteria

Adults with Dry Eye Disease (DED) who have specific symptoms and test results, like a SANDE score of 50mm or more, low tear production, short tear break-up time, or poor meibomian gland function. Not for those using other eye treatments, with recent eye surgery/injury/allergies, contact lens use in the last month, medication changes recently or during the study.

Inclusion Criteria

I did not respond to hypertonic saline treatment.

My level of discomfort or pain has not changed.

I have less pain or discomfort now.

Exclusion Criteria

You are allergic to a preservative called benzalkonium chloride (BAK) used in eye drops.

I haven't changed my medications in the last 3 months and don't plan to change them during the treatment.

I am using other skin treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive preservative-free artificial tears for 4 weeks, instilling one drop into each eye twice daily

4 weeks

1 visit (in-person)

Follow-up

Participants return for a follow-up visit where questionnaires and tests are repeated

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Preservative-free Refresh Optive Advanced Lubricant Eye Drops

Trial Overview The trial is testing preservative-free Refresh Optive Advanced Lubricant Eye Drops on two groups: one that responds to hypertonic saline and one that doesn't. Participants will use the drops twice daily for four weeks and undergo questionnaires and eye tests before and after treatment.

Participant Groups

Group I: Hypertonic Saline Responders Experimental Treatment 1 Intervention

Subjects who qualify as hypertonic saline responders will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days.

Group II: Hypertonic Saline Non-responders Experimental Treatment 1 Intervention

Subjects who qualify as hypertonic saline non-responders will be dispensed the same instructions and treatment as the Hypertonic Saline Responders. They will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days.

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Findings from Research

In a study involving 50 patients with dry eye, four preservative-free artificial tear treatments showed similar effectiveness in improving symptoms and signs of dry eye, as measured by various clinical assessments after 4 weeks of use.

Patient preferences varied, with Clinitas Soothe and Hyabak being the most liked overall, while TheraTears was favored by those with lower tear volume, indicating that individual characteristics can influence treatment choice despite similar efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the optimum artificial tear treatment for dry eye disease be predicted from presenting signs and symptoms? Essa, L., Laughton, D., Wolffsohn, JS.[2019]

In a study involving 231 adults with lipid-deficient dry eye, Systane® Balance (SYSB) was found to be non-inferior to Refresh® Optive Advanced (RFO-Ad) in improving tear film breakup time (TFBUT) after 35 days of use, indicating similar efficacy between the two treatments.

Both eye drop treatments significantly improved TFBUT and reduced ocular discomfort, and were well tolerated by participants, suggesting they are safe options for managing lipid-deficient dry eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease. Jerkins, G., Greiner, JV., Tong, L., et al.[2022]

In a study involving 28 participants with dry eye disease, both lipid-based (Systane Complete) and non-lipid-based (Systane Ultra) artificial tears improved symptoms and tear film stability after application.

However, the lipid-containing eye drop showed superior benefits in preserving tear film quality and reducing dry eye symptoms after exposure to adverse conditions, indicating it may be more effective for managing dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic action of lipid and non-lipid tear supplements in adverse environmental conditions: A randomised crossover trial. Muntz, A., Marasini, S., Wang, MTM., et al.[2021]

In a study of 110 non-contact lens wearers, a novel ocular lubricant provided significantly higher comfort ratings compared to a commercially marketed lubricant, with 71% of users reporting improved comfort.

While the novel lubricant showed better subjective comfort, objective clinical measures like visual acuity and tear quality were similar between both groups, indicating that the new lubricant is effective in enhancing user experience without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of the efficacy of a novel ocular lubricant. Dumbleton, K., Woods, C., Fonn, D.[2015]

Osmoprotective eye drops significantly lower tear osmolarity in contact lens wearers compared to a standard lubricant, indicating better eye hydration and protection.

Patients using osmoprotective eye drops reported higher comfort scores, suggesting that these drops not only help maintain tear quality but also enhance overall comfort during contact lens wear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of osmoprotective eye drops on tear osmolarity in contact lens wearers. Aslan Bayhan, S., Bayhan, HA., Muhafız, E., et al.[2016]

The new benzalkonium chloride-free Visine® lubricant eye drop formulation (GentlePur™) was found to be very comfortable for both healthy and dry eye subjects, with comfort scores improving over the 14-day study period.

The eye drops demonstrated safety with no significant adverse events reported, and they effectively reduced corneal staining in dry eye subjects, indicating potential benefits for ocular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and comfort evaluation of a new formulation of Visine(®) lubricant eye drops containing HydroBlend™ and GentlePur™. Torkildsen, G., Frisch, S., Bai, M., et al.[2020]

The study involving 45 contact lens wearers demonstrated that Systane Ultra Lubricant Eye Drops are safe to use, with no adverse events reported during the 14-day trial period.

Systane Ultra did not significantly affect visual acuity or corneal staining scores compared to a control solution, indicating its compatibility for contact lens wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-week clinical evaluation of the safety of Systane Ultra in contact lens-wearing patients. Kading, D.[2022]

In a study involving 210 patients with dry eye, the lipid-based lubricant eyedrop formulation (HPG/PG/PL) significantly improved tear film break-up time (TFBUT) compared to preservative-free saline, indicating better eye lubrication.

Patients using HPG/PG/PL reported a greater improvement in their quality of life related to dry eye symptoms, as measured by the Impact of Dry Eye on Everyday Life (IDEEL) scores, demonstrating its efficacy in enhancing daily comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. Baudouin, C., Galarreta, DJ., Mrukwa-Kominek, E., et al.[2022]

The study found that while all tested lubricant eye drops led to complete corneal healing by day 2, the Optive product caused progressive epithelial lesions by day 6, indicating potential corneal toxicity.

In contrast, Vismed Multi and Neopt did not adversely affect corneal integrity, suggesting they may be safer options for long-term use compared to Optive and Optive Fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of various lubricant eye drops on the in vitro rabbit corneal healing and toxicity. Dutescu, RM., Panfil, C., Schrage, N.[2017]

In a study of 60 patients with mild dry eyes, the lubricant eye drop containing polyethylene glycol 400 and sodium hyaluronate (Blink Intensive Tears) significantly reduced tear osmolarity compared to the other two tested drops, indicating better efficacy in improving eye moisture.

After 30 days of treatment, all lubricant eye drops improved tear osmolarity, but only Blink Intensive Tears showed a significant improvement in visual acuity, suggesting it may be the most effective option for treating dry, irritated eyes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tear osmolarity measurement using the TearLab Osmolarity System in the assessment of dry eye treatment effectiveness. Benelli, U., Nardi, M., Posarelli, C., et al.[2022]

A new hydrophilic polymer insert has been introduced as an alternative therapy for patients with dry eyes due to practolol syndrome, showing subjective and objective benefits compared to traditional preservative-free drops.

In this open study, no patients experienced retention issues with the insert, indicating good tolerability, although some still preferred the soothing effects of frequent eye drops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-release artificial tear inserts in the treatment of dry eyes resulting from the oculomucocutaneous syndrome. Wright, P., Vogel, R.[2019]

In a study of 50 participants with moderate ocular dryness, Systane(R) Lubricating Eye Drops significantly improved tear film break-up time (TFBUT) after 28 days of use, indicating better eye lubrication.

Participants reported significant relief from all six ocular discomfort symptoms, demonstrating both objective and subjective efficacy of Systane(R) in treating moderate ocular dryness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One month use of Systane improves ocular surface parameters in subjects with moderate symptoms of ocular dryness. Versura, P., Profazio, V., Campos, EC.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Can the optimum artificial tear treatment for dry eye disease be predicted from presenting signs and symptoms? [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Prophylactic action of lipid and non-lipid tear supplements in adverse environmental conditions: A randomised crossover trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An investigation of the efficacy of a novel ocular lubricant. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Effects of osmoprotective eye drops on tear osmolarity in contact lens wearers. [2016]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and comfort evaluation of a new formulation of Visine(®) lubricant eye drops containing HydroBlend™ and GentlePur™. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A two-week clinical evaluation of the safety of Systane Ultra in contact lens-wearing patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the effects of various lubricant eye drops on the in vitro rabbit corneal healing and toxicity. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Tear osmolarity measurement using the TearLab Osmolarity System in the assessment of dry eye treatment effectiveness. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Slow-release artificial tear inserts in the treatment of dry eyes resulting from the oculomucocutaneous syndrome. [2019]

12. New Zealand pubmed.ncbi.nlm.nih.gov

One month use of Systane improves ocular surface parameters in subjects with moderate symptoms of ocular dryness. [2021]