Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears

NCT01614847 | Completed Phase 4 Results FDA Drug

• 1 other identifier: NSUOCO-2012-11
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dry Eye

Keywords

dry eye; artificial tears; tear osmolarity; residence time

Outcome Measures

Primary Outcomes (1)

• Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes)

  Raw data: Baseline (pre-instillation) tear osmolarity was measured for right and left eyes for each subject. Then measurements were repeated at 7 times (5, 20, 35, 50, 65 890 and 95 minutes) after instillation. Data processing: 1) Baseline osmolarity was subtracted from each post-baseline measurement to give a change-from-baseline values. 2) Right and left eye change values averaged to give a mean osmolarity change for each subject at each of the seven times. 3) Mean osmolarity changes values were averaged across 8 subjects for each of the 7 times and entered in the table below. Row 1 is for Drop A (hyaluronate); Row 2 for Drop B (saline). Column are for the 7 times.

  Baseline, followed by 7 measurements made after instillation (5, 20, 35, 50, 65, 80, 95 minutes post-instillation).

Study Arms (2)

Isotonic hyaluronate artificial tear

EXPERIMENTAL

At random, subjects will receive isotonic hyaluronate artificial tear or a control (normal saline).

Drug: Artificial tears

Normal saline

PLACEBO COMPARATOR

Drug: Artificial tears

Interventions

Artificial tears DRUG

At random, subjects will receive isotonic artificial tear or a control (normal saline).

Isotonic hyaluronate artificial tear; Normal saline

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• No ocular disease other than dry eye Currently taking no ocular or systemic medications that might affect results

Sponsors & Collaborators

• Thomas O Salmon, OD, PhD: lead

Study Sites (1)

Northeastern State University

Tahlequah, Oklahoma, 74464, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Thomas O. Salmon, OD, PhD, Professor
• Organization: Northeastern State University Oklahoma College of Optometry

salmonto@nsuok.edu

918-444-4011

Study Officials

• Thomas O Salmon, OD, PhD

  Northeastern State University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)