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    Facts About Dry Eye

    This information was developed by the National Eye Institute to help patients and their families search for general information about dry eye. An eye care professional who has examined the patient's eyes and is familiar with his or her medical history is the best person to answer specificquestions.

    What isdryeye?

    Dry eye occurs when the quantity and/or quality of tears fails to keep the surface of the eye adequately lubricated. Experts estimate that dry eye affects millions of adults in the United States. The risk of developing dry eye increases with advancing age. Women have a higher prevalence of dry eye compared withmen.

    What are the symptoms of dryeye?

    Dry eye causes a scratchy sensation or the feeling that something is in the eye. Other symptoms include stinging or burning, episodes of excess tearing that follow periods of dryness, discharge, pain, and redness in the eye. People with dry eye may also feel as if their eyelids are heavy and may experience blurredvision.

    What are tears and how do they relate to dryeye?

    In a healthy eye, lubricating tears called basal tears continuously bathe the cornea, the clear, dome-shaped outer surface of the eye. With every blink of the eye, basal tears flow across the cornea, nourishing its cells and providing a layer of liquid protection from the environment. When the glands nearby each eye fail to produce enough basal tears, or when the composition of the tears changes, the health of the eye and vision are compromised. Vision may be affected because tears on the surface of the eye play an important role in focusinglight.

    Tears are a complex mixture of fatty oils, water, mucus, and more than 1500 different proteins that keep the surface of the eye smooth and protected from the environment, irritants, and infectious pathogens. Tears form in threelayers:

    What causesdryeye?

    Dry eye can occur when basal tear production decreases, tear evaporation increases, or tear composition is imbalanced. Factors that can contribute to dry eye include thefollowing:

    How is dry eyediagnosed andtreated?

    People experiencing dry eye symptoms should consult an eye care professional to determine the cause, which guides treatmentstrategy.

    Change medications. Consult a physician about switching medications to alternative ones that are not associated with dry eye. This may alleviate dry eyesymptoms.

    Over-the-counter (OTC) topical medications. Mild dry eye symptoms may be treated with over-the-counter medications such as artificial tears, gels, andointments.

    Environmental and lifestyle changes. Cutting back on screen time and taking periodic eye breaks may help. Closing the eyes for a few minutes, or blinking repeatedly for a few seconds, may replenish basal tears and spread them more evenly across the eye. Sunglasses that wrap around the face and have side shields that block wind and dry air can reduce symptoms in windy or dryconditions.

    In cases of Meibomian gland dysfunction, warm lid compresses and scrubs may behelpful.

    Smoking cessation and limiting exposure to secondhand smoke also mayhelp.

    Prescription dry eye medications. Cyclosporine and lifitegrast are the only prescription medications approved by the U.S. Food and Drug Administration for treating dry eye. Corticosteroid eye drops also may be prescribed short-term to reduce eyeinflammation.

    Devices. FDA-approved devices provide temporary relief from dry eye by stimulating glands and nerves associated with tearproduction.

    Surgical options. Punctal plugs made of silicone or collagen may be inserted by an eye care professional to partially or completely plug the tear ducts at the inner corners of the eye to keep tears from draining from the eye. In severe cases, surgical closure of the drainage ducts by thermal punctal cautery may be recommended to close the tear ducts permanently.

    What research is NEI supporting to improve treatments for dry eye? NEI-supported researchers are studying the underlying causes of dry eye to better understand the disease and to develop noveltreatments.

    In a healthy eye, only one-tenth of a degree of cooling from evaporation is needed for activation of nerves that trigger basal tearing. Researchers are investigating factors that influence the ability of corneal nerves to sense tear evaporation. Such research may lead to the development of topical corneal nerve stimulators, or products that increase nerve sensitivity todrying.

    The protein lacritin in tears promotes basal tearing (via nerve stimulation) and eye health. Some people with dry eye have low levels of lacritin in their tears. A topical, synthetic form of the protein has been developed for initial testing in people with dryeye.

    Since corneal nerve number, length, and function are substantially diminished in dry eye, another research goal is to devise ways to promote their regrowth. Such a product could also help individuals suffering from dry eye after corneal laser surgery, such asLASIK.

    Other research is exploring the role of stem cells in the natural development of lacrimal glands. This early-stage research may eventually enable use of a patient's own stem cells to rebuild or replace tear-producing lacrimalglands.

    Investigation is ongoing into the molecular composition of the tear lipid layer, and factors that either stabilize or destabilize it. Treatments to stabilize it may help reduce tearevaporation.

    Last Reviewed:
    July 2017

    *PDF files require the free Adobe® Reader® (link is external) software forviewing.

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    Figure 1 Methods of data handling with missing data on progression.

    At least nine events are related in assessing PFS: I. Local regional relapse; II. Distant metastases; III. Second primary tumor-same entity; IV. Second primary tumor-other entity; V. *Death related to tumor; VI. *Death related to another tumor; VII. *Tumor independent death; VIII. *Death related to tumor therapy; IX. Lost to Follow-up: Censored. All events marked by * are also covered by OS ( Figure 2 ) ( 41 ).

    Figure 2 All events of OS are covered by PFS; PFS shows additionally the events of tumor control.

    To demonstrate the impact of sample size Figure 3 illustrates calculation for trials where the surplus in overall survival varies. Sample size is calculated by the log rank test (Freedman) under the assumption that in the two groups the hazards are proportional (PASS 11, version 11.0.7, 2011) ( 42 , 43 ). Further on, it is assumed that the survival times are exponentially distributed. If the median survival of the control group is 12 months then the 1-year survival rate is 50%. An increase of 10% to a 1-year rate of 55% is equivalent to a survival of 14 months. A rate of 60% corresponds to 16.3 months, 65% to 19.4 months, and 70% to 23.4 months, nearly doubling the survival time. For superiority the one-sided test is used. The power was set to 90% or 80% and α=0.025 or α=0.05. Accrual is 1 : 1 for the two groups. The sample sizes vary between N=4059 and N=151 depending on the power, significance and survival proportion. A small incremental increase in survival time accompanied by small error rates (power and α) leads to a large study population.

    Figure 3 Sample size calculation for proportion of 1-year survival of 0.55-0.70 of experimental group versus 1-year survival of 0.5 for controls in a 1:1 recruitment and with power of 80% or 90% and α=0.025 or α=0.05.

    The main factor for PFS to predict OS is the duration of PFS ( 43 ). A significant survival gain can be predicted in a trial of 750 patients if 18% of patients responding to treatment. 500 patients are needed if 21% of patients respond and if it is postulated that 30% patients respond, at least 250 patients must be enrolled.

    The necessary incremental gain for PFS to predict a survival improvement was a median of 1.7 months for trials with 750 patients, 2.2 months for 500 patients, and 3.3 months for trials with 250 patients. Hence, a significant surplus on PFS can only be predictive for OS if the sample is big enough. Statistically it comes to compare PFS and OS as two failure time distributions in the presence of censoring, where the distribution is shifted due to the different time interval of measurement ( 44 ). Compared to OS in PFS more competing risks are included ( Figure 2 ). PFS as surrogate endpoint for OS can also be investigated by the aid of a stochastic model ( 45 ). The Process was demonstrated theoretically by a statistical OS model with two independent stochastic processes defining an interim and a restart point of progression. Since it has been discovered that the interval after progression to death may have similar distribution for most of the lung cancer trials PFS as a surrogate of OS seem to be reasonable ( 46 , 47 ). The strongest prediction of PFS for OS results from a high correlation of PFS and OS and a high treatment effect homogeneity ( Figure 4 ).

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