Methods for application of tear-based biomarkers to ophthalmic product evaluation and clinical study management
OwnerRobert Edward Campbellinventor
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Abstract
Methods and test kits for characterizing and evaluating a mammal's ocular defenses and health are disclosed. More particularly, the invention concerns methods and test kits directed to measurements and subsequent comparative evaluations of tear constituents indicative of ocular defenses and health including antioxidants, antimicrobials, inflammatory mediators, and byproducts of cellular damage.
Claims48
A method for characterizing and evaluating the effect of one or more products or services on the ocular defenses or health of one or more mammals in a clinical, research or other study comprising:
- (a) optionally taking one or more samples of tear fluid from one or both eyes of a mammal before exposure to a product or service under study;
- and
- (b) taking one or more samples of tear fluid from one or both eyes of a mammal after exposure to a product or service under study;
- and
- (c) measuring the levels of one or more tear constituents in said tear fluid sample(s);
- and
- (d) using the measured levels of tear constituent(s) to characterize and evaluate the effect of a product or service under study on the ocular defenses or health of one or more mammals in the study.
A method for screening mammals for inclusion in a clinical, research or other study comprising:
- (a) taking one or more samples of tear fluid from one or both eyes of a mammal prior to inclusion in the study;
- and
- (b) measuring the levels of one or more tear constituents in said tear fluid sample(s);
- and
- (c) using the measured levels of tear constituent(s) to characterize and evaluate the mammal's ocular defenses or health and to aid in determining the mammal's inclusion in the study.
A method for screening mammals for differential handling in a clinical, research or other study comprising:
- (a) optionally taking one or more samples of tear fluid from one or both eyes of a mammal before exposure to a product or service under study;
- and
- (b) taking one or more samples of tear fluid from one or both eyes a mammal after exposure to a product or service under study;
- and
- (c) measuring the levels of one or more tear constituents in said tear fluid sample(s);
- and
- (d) using the measured levels of tear constituent(s) to characterize and evaluate the mammal's ocular defenses or health and to aid in determination of whether to continue the mammal in the study and, if so, on what basis.
A method for characterizing the ocular defenses or health of one or more mammals for use as a comparative base, comprising:
- (a) optionally taking one or more samples of tear fluid from one or both eyes of a mammal before exposure to one or more selected products or services;
- and
- (b) optionally taking one or more samples of tear fluid from one or both eyes of a mammal after exposure to one or more selected products or services;
- and
- (c) measuring the levels of one or more tear constituents in said tear fluid sample(s);
- and
- (d) using the measured levels of tear constituent(s) to characterize the ocular defenses or health of one or more mammals.
Dependencies are inferred from the claim text.