Why is the Lacrimation Test Performed?

Ocular tolerance examinations assess the safety and suitability of eye-related products, such as contact lenses, eye drops, or ointments, for use in the eyes. These examinations evaluate how well the product is tolerated by the ocular surface, including the tear film, cornea, conjunctiva, and other ocular tissues. The lacrimation test is performed for the development of ophthalmic compounds to evaluate their possible effects on the eye. Lacrimation refers to the production of tears, and this test measures the ability of a compound to stimulate or inhibit tear secretion, thus ensuring their safety, efficacy, and compliance with regulatory requirements.

Service Overview

As a preclinical ophthalmic research CRO, Ace Therapeutics conducts safety and efficacy evaluations across all ophthalmic indications. We are pleased to offer unrivaled lacrimation tests of your ophthalmic products as part of ocular tolerance studies.

Ace Therapeutics' lacrimation tests assess the compatibility and safety of a substance or product with the eye. It involves dropping a small amount of a substance into a model (rabbit, canine, rat, minipig, etc.) eye to observe its effect on tear production and potential irritation or adverse reactions. The lacrimation testing service allows you to predict and quantify possible ocular side effects of your ophthalmic products.

Access Ace Therapeutics' Lacrimation Tests of Ophthalmic Compounds

Ace Therapeutics performs a lacrimation test using the following protocol.

• Experiment Procedure

• Eye examination of the test animals (albino rabbits): Before the test, the animals should adapt to the animal laboratory environment for at least 3 days. 24 hours before the trial, both eyes of the experimental animals should be thoroughly examined. Animals with corneal defects or conjunctival lesions with eye irritation symptoms should not be used.
• Groups: 9 albino rabbits were divided into three groups, including the test product group, the vehicle (when applicable) group, and the control substance (pilocarpine) group. 
• Administration: Using a dropper or suitable applicator, instill the prescribed volume of the continued compound into one eye of the rabbit. (Topical medication, iontophoresis...)
• Evaluation: Observe the treated rabbit's eye for specified periods of time (e.g., 1, 5, 15, 30, and 60 minutes) following instillation, and the tear volume was collected using Schirmer strips or microcapillaries.
• Parameters: Quantity of tears collected in 5 min.
• Repeat the test: If necessary, the experiment will be repeated with the same or different compounds to validate the results or evaluate dose-dependent effects.
• Guidelines: Guideline on non-clinical local tolerance testing of medicinal products - EMA/CHMP/SWP/2145/2000 Rev. 1 Corr.

Note*: Ace Therapeutics' lacrimation test services can be adjusted to meet specific requirements according to the characteristics of your product, such as structural characteristics, physicochemical properties, indication characteristics, and test purposes. Importantly, our talented scientists will also conduct a comprehensive evaluation of the test results in combination with other pharmacological and toxicological information to help you reduce asset risks before entering IND-supported studies.

What Problems Can We Solve?

• Safety assessment: Our lacrimation test helps determine whether a compound has any irritant or toxic effects on the eye. If a compound causes excessive tearing, it may be an indication of irritation or damage to the ocular surface. Conversely, if a compound suppresses tear production, it may cause dryness and discomfort.
• Therapeutic efficacy: Certain ophthalmic compounds are designed to treat conditions associated with tear deficiency, such as dry eye syndrome. Our lacrimation test can assess the effectiveness of these compounds in stimulating tear production, thus determining their therapeutic value.
• Regulatory requirements: Regulatory authorities often require evaluation of tear production during the development of ophthalmic compounds. The lacrimation test provides valuable data to assess the safety and efficacy of your ophthalmic compounds, ensuring their compliance with regulatory standards.
• Formulation development: Our lacrimation test can aid in the formulation development of your ophthalmic compounds. By evaluating their impact on tear secretion, our researchers can optimize the formulation to enhance tear production or reduce adverse effects, resulting in improved patient compliance and comfort.

The goal of Ace Therapeutics' lacrimation test services is to help you understand the effects of ophthalmic compounds on tear production, ensuring their safety, efficacy, and compliance with regulatory requirements. If you are interested in our services or need more detailed information, please feel free to contact us. Our experienced scientists are ready to help you!

• Acute Local Toxicity Testing of Ophthalmic Drugs
• Chronic Local Toxicity Testing of Ophthalmic Drugs
• Maximum Tolerated Dose (MTD) Testing of Ophthalmic Drugs
• Corneal Anesthesia Testing of Ophthalmic Drugs
• Pupil Diameter Testing of Ophthalmic Drugs

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