CLINICAL TRIAL

Artificial tear for Dry Eye

Waitlist Available · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether a higher concentration of cyclosporine may be more effective for dry eye conditions.

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About the trial for Dry Eye

Eligible Conditions
Dry Eye Syndromes · Keratoconjunctivitis Sicca · Dry Eyes

Treatment Groups

This trial involves 2 different treatments. Artificial Tear is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Artificial tear
DRUG
Cyclosporine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artificial tear
2013
Completed Phase 4
~210
Cyclosporine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosed with Dry Eye, but who have not been prescribed a drug to treat this condition.
18 years of age and older
OSDI score > 12
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Last follow-up (Month 6).
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Last follow-up (Month 6)..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Artificial tear will improve 1 primary outcome and 1 secondary outcome in patients with Dry Eye. Measurement will happen over the course of At the time of sample collection (Baseline and Month 6)..

Tear Film Cytokines
AT THE TIME OF SAMPLE COLLECTION (BASELINE AND MONTH 6).
Change from Baseline in tear film cytokines at 6 months. The tear fluid samples would be analyzed by ELISA for: Matrix metalloproteinase-9; SLURP-1; HLA-DR5; IL-1RA; IL-6; and IL-8.
OSDI Score
LAST FOLLOW-UP (MONTH 6).
Change is Ocular Surface Disease Index (OSDI) score at Month 6. The OSDI quickly assesses the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

Patient Q & A Section

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

What is dry eye?

Dry eye is an increasingly common ocular condition, affecting 6% to 13% of the general population, with a high prevalence in women. Patients are more commonly treated in ophthalmic practice and ocular subspecialties. Its natural course is chronic and most patients will be diagnosed without intervention in their lifetime. In the United Kingdom in 2010, the National Eye Dry Eye Hospital Service reported 5,834 treatments performed, and there were 27,531 referrals made, with a projected rate of 5.1 referrals per 10,000 general optometrists.

Anonymous Patient Answer

What causes dry eye?

The tear meniscus is a major structure thought to be the cause of DED. However, the meniscus is not the only morphologic alteration to occur in patients with DED. Further, we have found morphological abnormalities in patients with DED in the absence of tear meniscus changes. Results from a recent paper suggest other morphologic changes, including changes of the zonular complex, are also involved in the development of DED.

Anonymous Patient Answer

How many people get dry eye a year in the United States?

In the United States, at least 500,000 people are thought to be affected by dry eye. Dry eye symptoms are very common and may have significant negative health consequences. Dry eye is thought to be underrecognized, and is underestimated as a contributor to dry eye disease and as a cause of vision impairment and/or problems with lens health. The National Eye Institute has identified that women in particular are at risk.

Anonymous Patient Answer

What are the signs of dry eye?

Symptoms of dry eye can include a red eye, sensitivity to light, a foreign body sensation, tear evaporation and photophobia. In addition, abnormalities of tear film may predispose the eye to the development of ocular infections.

Anonymous Patient Answer

What are common treatments for dry eye?

There is no agreement on what is and is not effective treatment for dry eye. The lack of consensus on an effective or inappropriate treatment can be attributed to inadequate evidence in the literature, difficulty in measuring efficacy, and the lack of consensus among specialists regarding the optimal treatment and monitoring of dry eye.

Anonymous Patient Answer

How serious can dry eye be?

Dry eye is fairly common but most people have no significant symptoms. In moderate to severe cases of dry eye there is a substantial risk of permanent visual deterioration and loss of vision. Treatment is important regardless of whether or not there is vision loss. This is a rare but alarming finding because there is a tendency for people who suffer from dry eye to have a higher risk of developing a number of major diseases, including diabetic retinopathy, corneal breakdown and retinal detachments. It seems logical that treatment of dry eye, if necessary, should be as quick and as effective as possible to minimise loss of vision. Patients who experience worsening of their symptoms should seek help as soon as possible.

Anonymous Patient Answer

How does artificial tear work?

Artificial tear drops contain lubricant, which reduces evaporation of the tears. Artificial tears can be easily confused with lubricants, because they often have similar visual effects. Although there is a myth that artificial tears can calm the eyes and reduce pain, this is not the case. There are a number of artificial tears that are available in different formulations and strengths, but they usually include all sorts of chemicals to ensure that the tear is as close to the correct chemical composition as possible. These are often used during times where there is a lack of natural tears, such as the night before or before surgery.

Anonymous Patient Answer

What is the latest research for dry eye?

It is a disease that can be cured by avoiding eye injuries. The only way to avoid dry eye is to take precautions when looking at the eye. The best way to treat it is to see a professional. There are many products to try out that are marketed as “SODEX” or “SOREX”. The companies have invested millions of dollars into these types of products but even though they are advertised as being a great treatment, there isn't a lot of evidence that the products work. Studies have been done to test and prove how the SODEX or SOREX therapies really work.

Anonymous Patient Answer

Does dry eye run in families?

A positive effect of topical corticosteroid application is noted in a minority of ocular symptoms in patients with dry eyes. A family history of an ocular/ophthalmic manifestation of the disease may be associated with a higher likelihood of ocular involvement.

Anonymous Patient Answer

What is the average age someone gets dry eye?

The incidence of dry eye increases with age. A large percentage of patients present with dry eye early in life and even a relatively small percentage with extreme dry eye complaints experience complete remission in middle adulthood. It remains imperative to monitor for this condition at least 5 years after the onset of signs and symptoms.

Anonymous Patient Answer

What does artificial tear usually treat?

These data suggest that in cases of chronic and severe dry eye, artificial tears will lead to an increased rate of epithelial deterioration and a more rapid progression of autoimmune corneal disease, especially that characterized by lacunar corneal changes and a loss of the corneal epithelium with subsequent severe desiccation and desquamation. In addition, these studies suggest that patients with chronic and severe dry eyes should not receive artificial tear therapy.

Anonymous Patient Answer
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