Artificial tears are ophthalmic preparations (solutions or ointments) used for the relief of dry eyes (xerophthalmia) and ocular irritation. Selected lubricant products [containing a combination of tyloxapol and benzalkonium chloride (BAK)] can be used as a cleaning agent and lubricant for ophthalmic prostheses. Artificial tears have also served as a vehicle for ocular preparations of acetylcysteine used to treat giant papillary conjunctivitis (GPC), while artificial tears alone have been used for milder cases of this condition. Artificial tears products contain varying formulations that maintain ocular tonicity. Artificial tears solutions usually consist of a vehicle to stabilize the tear film and promote wetting; buffering agents, preservatives, pH content and other factors may vary from product to product. Popular vehicles found in artificial tear solutions include, but are not limited to, carboxymethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, polyvinyl alcohol and povidone. Artificial tear ointments usually contain a bland (non-medicated) ophthalmic ointment vehicle to lubricate the eye; the primary ingredients are usually white petrolatum, mineral oil and lanolin. Modern artificial tear formulations were first developed in the mid-1940s with the introduction of synthetic methylcellulose, but historically, many agents had been tried clinically for hundreds of years to relieve dry eyes. Today, most products are available without a prescription in the United States. To date, an ideal replacement for the human tear layer has not been found.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-For topical ophthalmic application only. Do not ingest internally.
-Wash hands well before use.
-Remove contact lenses prior to use unless the product specifies that contact lenses may be worn in application (e.g., Clear Eyes CLR).
Artificial Tears ophthalmic solutions:
-If the patient has other eye drops of any type prescribed along with artificial tears, separate the application of the different eye drops by roughly 5 minutes. This ensures that the eye drops do not interfere with each other. If the patient is administered both eye drops and an eye ointment, use the eye drops 10 minutes before the eye ointment so that the eye ointment does not interfere with the action of the drops.
-Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and close eyes for 1-2 minutes.
-Have the patient close the eye(s) gently for a few moments to allow contact.
-Care should be taken to avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surface. Replace cap when not in use.
-Use only one open bottle per patient to avoid contamination.
-If the solution changes color or becomes cloudy, discontinue use and obtain a new bottle.
Artificial Tears ophthalmic ointments:
-If the patient is administered both eye drops and an eye ointment, use the eye drops 10 minutes before the eye ointment so that the eye ointment does not interfere with the action of the drops.
-Gently pull down the lower lid of the affected eye(s) and apply a small amount of ointment (roughly one-fourth (1/4) of an inch) to the inside of the eyelid.
-Have the patient close the eye(s) gently for a few moments to allow contact.
-Wipe away any excessive residue with a clean tissue.
-Care should be taken to avoid contamination. Do not touch the tip of the tube to the eye, fingertips, or other surface. Replace cap when not in use.
-Use only one open tube per patient to avoid contamination.
Artificial tears products produce few side effects. Temporary stinging or blurred vision may occur on drop or ointment application; blurred vision upon application is commonly reported with the use of lubricant ointments. Irritation of ocular tissues typically does not occur with the vehicles commonly found in artificial tear solutions. Serious adverse reactions to artificial tears products, particularly lubricant ointments, are rare. Rarely, allergy or sensitivity, including contact dermatitis/allergy, can occur to specific product ingredients, such as preservatives in artificial tear solutions. A preservative-free product can limit the risk of a sensitivity reaction. Discontinue use of the specific product if ocular pain, ocular pruritus or other ocular irritation symptoms occur or worsen, or if the condition has not improved within 72 hours of use of the product; the patient should consult their health care professional for ophthalmic evaluation.
Some artificial tears solutions are formulated with preservatives (e.g., benzalkonium chloride) that may be absorbed by soft contact lenses. It is recommended that contact lenses be removed prior to the administration of artificial tears products unless the product specifies that contact lenses may be worn in application (e.g., Clear Eyes CLR). Patients with contact lenses who present with eye irritation should be evaluated by a practitioner prior to self-treating the condition with artificial tears.
Consult a health care professional for patient evaluation prior to use of artificial tears if corneal abrasion, ocular infection, foreign body trapping or ocular trauma is suspected. If visual disturbance is present, the patient requires evaluation by a practitioner to determine appropriate treatment.
Artificial tears products have not been assigned a specific FDA pregnancy risk category rating. These ophthalmic products are not expected to pose significant problems during pregnancy due to lack of systemic absorption of the active vehicles. As with any drug in pregnancy, use should be determined by medical necessity and only under the direction of a health care provider. Select preservative-free products when possible, and limit use to the lowest dosage and shortest duration feasible to treat the condition.
If non-prescription artificial tears products are to be used in neonates, infants or children < 6 years, a health care professional should be consulted for evaluation prior to use.
Artificial tears ophthalmic products are not expected to pose significant problems during breast-feeding due to lack of systemic absorption of the active vehicles. As with any drug in breast-feeding, use should be determined by medical necessity and only under the direction of a health care provider. Select preservative-free products when possible, and limit use to the lowest dosage and shortest duration feasible to treat the condition. To minimize the amount of drug that reaches systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after each application.
For the treatment and prevention of dry eye disease:
Ophthalmic dosage (eye solution and eye gel):
Adults: 1 to 2 drops in the affected eye(s) once daily or more as needed.
Infants, Children, and Adolescents: 1 to 2 drops in the affected eye(s) once daily or more as needed.
Ophthalmic dosage (eye ointment):
Adults: One-fourth inch in the affected eye(s) once daily or more as needed.
Infants, Children, and Adolescents: One-fourth inch in the affected eye(s) once daily or more as needed.
Maximum Dosage Limits:
-Adults
No maximum dosage limit applies.
-Elderly
No maximum dosage limit applies.
-Adolescents
No maximum dosage limit applies.
-Children
>= 6 years: No maximum dosage limit applies.
< 6 years: No maximum dosage limit applies; consult health care professional before use.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Artificial Tears products.
The surface active properties of the vehicles found in artificial tears solutions act to stabilize the tear film and increase tear viscosity to prevent tear evaporation and retard tear drainage. Agents like povidone additionally mimic the action of mucin, the inner tear film layer that promotes wetting and adhesion of tears to the ocular surface. The vehicles found in bland lubricant artificial tear ointments also enhance the tear film and additionally have a prolonged duration of action in the eye versus artificial tear solutions.
Pharmacokinetics:
Artificial tears solutions and ointments are applied topically to the eye.
-Route-Specific Pharmacokinetics
Other Route(s)
Ophthalmic Route
Ointments are not systemically absorbed and contain no medicated ingredients. No pharmacokinetic data are available for ophthalmic solutions; it is expected that the formulas act locally and are not systemically absorbed.