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Tear Osmolarity Over Time With Artificial Tears

H

Hom, Milton M., OD, FAAO

Status and phase

Unknown
Phase 4

Conditions

Dry Eye

Treatments

Drug: Artificial tears

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The effect of artificial tears on tear osmolarity

Full description

Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)

Exclusion criteria

Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 4 patient groups

Refresh tears
Active Comparator group
Description:
Allergan's Refresh tears artificial tear
Treatment:
Drug: Artificial tears
Systane Ultra
Active Comparator group
Description:
Alcon's Systane Ultra artificial tear
Treatment:
Drug: Artificial tears
Visine
Active Comparator group
Description:
Visine artificial tear
Treatment:
Drug: Artificial tears
Blink tears
Active Comparator group
Description:
AMO's blink tears artificial tear
Treatment:
Drug: Artificial tears

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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