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Artificial Tears

Eye Drops for Dry Eye Syndrome (PreDICT Trial)

Phase 4

Recruiting

Led By Stephanie Cox, OD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No change of discomfort/pain rating

At least 18 years of age

Must not have

Active ocular allergies or other condition that could impact the study results

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying whether artificial tears help people with dry eye disease who do not respond to treatment with hypertonic saline solution.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of lubricant eye drops can include temporary visual blurring after application, mild stinging or burning sensation in the eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My level of discomfort or pain has not changed.

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I am 18 years old or older.

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My eye has dryness and tear issues confirmed by tests.

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I have severe dry eye symptoms.

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I have severe dry eye symptoms.

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My level of discomfort or pain has not changed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have eye allergies or conditions that might affect study outcomes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in SANDE severity score response from visit 1 to visit 2

Secondary study objectives

Body Weight Changes

Change in meibomian gland expression from visit 1 to visit 2

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hypertonic Saline RespondersExperimental Treatment1 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-respondersExperimental Treatment1 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.

0 / 7Eligibility criteria met