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Eye Drops for Dry Eye Syndrome (PreDICT Trial)
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.
PreDICT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPreDICT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PreDICT Trial Design
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Who is running the clinical trial?
Media Library
- I did not respond to hypertonic saline treatment.I am 18 years old or older.If you experience an increase in pain or discomfort greater than one level during the study, you won't be able to continue participating.You are able to understand and agree to participate in the study.My level of discomfort or pain has not changed.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.I have less pain or discomfort now.My pain has increased by 1 step or less.I am 18 years old or older.My eye has dryness and tear issues confirmed by tests.My eye has dryness and tear issues confirmed by tests.I have severe dry eye symptoms.I have eye allergies or conditions that might affect study outcomes.I have not had eye surgery, eye infections, or eye injuries in the last 3 months.I have been diagnosed with dry eye disease.I have severe dry eye symptoms.My level of discomfort or pain has not changed.I have been diagnosed with Dry Eye Disease.I am 18 years old or older.I did not respond to hypertonic saline treatment.You have been wearing contact lenses in the past month.My pain has increased by a small amount or not at all.My pain or discomfort has decreased.
- Group 1: Hypertonic Saline Responders
- Group 2: Hypertonic Saline Non-responders
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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