Mode
Text Size
Log in / Sign up
Phase 4 N=8 Randomized Double-blind Treatment

Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears

Dry Eye

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes) — -0.94; 7.25; 5.31; -4.25 mOsmols/L — p=0.4

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Artificial tears (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Thomas O Salmon, OD, PhD
Primary completion
Aug 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes)
-0.94; 7.25; 5.31; -4.25; 7.5; 2.31 0.4

Summary

Background: Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears contain various dissolved particles including proteins, salts and other electrolytes. The investigators plan to investigate how osmolarity of the tear film changes over time after instillation of artificial tears containing hyaluronate. This is one kind of artificial tear that is used to treat dry eye. Dry eye and tear osmolarity: Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and ineffective. There has been a resurgence of interest and research in dry eye in the past 5 years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate tear quality and dry eye status. Dry eye is usually treated with artificial tears, and many formulations are available. The investigators will test an isotonic solution that contains hyaluronate. Hyaluronate binds water and should help to maintain water on the eye. Objective: We plan to study the time course of possible changes in tear film osmolarity following instillation of an isotonic artificial tear containing hyaluronate. The investigators will use the TearLab, a new clinical instrument that has been developed to quickly and easily measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity over time can help doctors determine efficacy and dosing schedules. The investigators will test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline solution. Hypothesis: The investigators should be able to measure a decrease in tear osmolarity over time following instillation due to the water-binding effect of hyaluronate artificial tears relative to a control (normal saline solution).

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age Normal vision in both eyes (20/30 best corrected) Preference for patient with dry eye symptoms

Exclusion Criteria

  • No ocular disease other than dry eye Currently taking no ocular or systemic medications that might affect results
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01614847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search