Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops

NCT00610480 | Completed Results DMC

• 1 other identifier: 092007-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.

Conditions

Dry Eye Disease

Keywords

Dry Eyes; Tear Film Stability

Outcome Measures

Primary Outcomes (1)

• Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears

  To evaluate the effect of OTC artificial tears on tear film stability, the evaporation rate (µl/cm2/min) will be determined with an Evaporometer for the left eye only of each patient. For each arm, the evaporation rates will be determined at baseline and at 30 minutes after installation of artificial tears. Evaporation rates in all cases will be determined under two different relative humidity (RH) conditions, RH from 25-35% and RH from 35-45%.

  Baseline and 30 minutes after artificial tear instillation

Study Arms (2)

Optive, then Systane Artificial Tears

ACTIVE COMPARATOR

Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, artificial tears (Systane, 40 microliters) will be administered using the same procedure protocol.

Drug: 1st visit Optive, then 2nd visit Systane

Systane, then Optive Artificial Tears

ACTIVE COMPARATOR

Artificial Tears (Systane, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, artificial tears (Optive, 40 microliters) will be administered using the same procedure protocol.

Drug: 1st visit Systane, then 2nd visit Optive

Interventions

1st visit Optive, then 2nd visit Systane DRUG

First visit: Instillation of Optive followed by evaporometry assessment after 30 minutes. Second visit: Instillation of Systane followed by evaporometry assessment after 30 minutes.

Optive, then Systane Artificial Tears

1st visit Systane, then 2nd visit Optive DRUG

First visit: Instillation of Systane followed by evaporometry assessment after 30 minutes. Second visit: Instillation of Optive followed by evaporometry assessment after 30 minutes.

Systane, then Optive Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 and up will be included, where any age over 89 will be recorded as 'greater than 89.'
• Individuals with bilateral eye sight eye correctable to 20/80 or better.
• Individuals in good health with or without Meibomian Gland Dystrophy (MGD) but with Aqueous Tear Deficiency (ATD) with minimal to no ocular surface inflammation on slit lamp examination.

You may not qualify if:

• Individuals with only one sighted eye or vision not correctable to 20/80 or better in both eyes.
• Individuals with history of punctal plugs or punctal occlusions.
• Individuals with history of keratorefractive as well as ophthalmic disease such as corneal dystrophies, glaucoma, or systemic disease affecting the eye (such as Herpes Zoster).
• Individuals with history of systemic or ocular auto-immune conditions.
• Individuals with active systemic disease or those taking systemic medication that are known to influence AT production will not be considered for this trial.
• Individuals using topical medication who are unable to discontinue them for at least 24 hours prior to baseline evaluation will be excluded as well.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSW Medical Center at Dallas - Aston Ambulatory Care Center

Dallas, Texas, 75390-9057, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Peter Chen
• Organization: UT Southwestern Medical Center

peter.chen@utsouthwestern.edu

214-648-3837

Study Officials

• Vinod Mootha, MD

  UTSW Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2008
• First Posted: February 8, 2008
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)