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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
Group 1 (Hypertonic saline non-responders):
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

PreDICT 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.Check my eligibility
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.See study design
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.

PreDICT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I did not respond to hypertonic saline treatment.
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I am 18 years old or older.
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My level of discomfort or pain has not changed.
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I have less pain or discomfort now.
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My pain has increased by 1 step or less.
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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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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 been diagnosed with dry eye disease.
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I have severe dry eye symptoms.
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My level of discomfort or pain has not changed.
Select...
I have been diagnosed with Dry Eye Disease.
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I am 18 years old or older.
Select...
I did not respond to hypertonic saline treatment.

PreDICT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in SANDE severity score response from visit 1 to visit 2
Secondary outcome measures
Body Weight Changes
Body Weight Changes
Change in meibomian gland expression from visit 1 to visit 2
+2 more

PreDICT 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.

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,948 Total Patients Enrolled
Stephanie Cox, ODPrincipal InvestigatorTufts Medical Center New England Eye Center

Media Library

Preservative-free Refresh Optive Advanced Lubricant Eye Drops (Artificial Tears) Clinical Trial Eligibility Overview. Trial Name: NCT04125134 — Phase 4
Dry Eye Syndrome Research Study Groups: Hypertonic Saline Responders, Hypertonic Saline Non-responders
Dry Eye Syndrome Clinical Trial 2023: Preservative-free Refresh Optive Advanced Lubricant Eye Drops Highlights & Side Effects. Trial Name: NCT04125134 — Phase 4
Preservative-free Refresh Optive Advanced Lubricant Eye Drops (Artificial Tears) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04125134 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies does Preservative-free Refresh Optive Advanced Lubricant Eye Drops typically alleviate?

"Preservative-free Refresh Optive Advanced Lubricant Eye Drops are commonly used to treat eye conditions, but also can be beneficial for managing dyschezia, scalp health and fluorophotometry."

Answered by AI

Are there available vacancies for participants of this research?

"Affirmative, clinicaltrials.gov displays that the trial is actively searching for volunteers as of January 7th 2022. The study was first listed on October 3rd 2019 and seeks to enlist 66 participants from a single centre."

Answered by AI

What is the regulatory standing of Preservative-free Refresh Optive Advanced Lubricant Eye Drops?

"After careful consideration, our team at Power concluded that Preservative-free Refresh Optive Advanced Lubricant Eye Drops is safe and rated it a 3 on the safety scale. This result stems from its Phase 4 trial status which indicates the treatment has been approved for use."

Answered by AI

What is the aggregate participation of this research endeavor?

"Indeed, the information accessible on clinicaltrials.gov indicates that this clinical trial is actively seeking participants. Posted initially on October 3rd 2019 and recently updated in January 7th 2022, it has opened 66 positions between 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Alberta
Texas
How old are they?
18 - 65
What site did they apply to?
Tufts Medical Center-New England Eye Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
~9 spots leftby Dec 2024