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

28 oktober 2020 bijgewerkt door: V. Vinod Mootha, University of Texas Southwestern Medical Center

Effects of Systane® Versus Optive™ Lubricating Eye Drops in Maintaining Tear Film Stability at Determined Time Points

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Twenty (20) patients will be enrolled in this two-period crossover, randomized study design. During the course of the study, each patient will be treated with each test article in the clinic at separate visits. Following the informed consent procedure, a general ocular evaluation, including corneal and conjunctival staining and Schirmer testing, will be done and evaporometry assessments will be completed to determine baseline tear evaporation rate. This will occur before any test article is administered to the patient.

Qualified patients will be randomized into two treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl) or Optive™ (40 µl) in each eye per randomization assignment. At 30 minutes following instillation of the drop, the evaporometry measurement will be repeated. These evaporometry tests (pre and post instillation of drops) will be performed in order to establish a comparison for later analysis. The estimated time in completing each study visit will be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days for evaluation of the 2nd assigned crossover treatment (i.e. patients who initially received Optive will receive Systane and patients who initially received Systane will receive Optane).

During the interim study periods, patients will be asked to continue their pre-study routine; using their pre-study ocular lubricant or other tear products at the same frequency. Any changes in the frequency of product use during the interim period or any changes in other concomitant medications will be carefully recorded. This is especially important since many prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology.

An effort will be made to schedule all study visits at approximately the same time of day in order to reduce diurnal variability. For the similar reasons, all patients will be asked not to use any lubricants or ocular medications for at least one hour prior to their office visits.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Dallas, Texas, Verenigde Staten, 75390-9057
        • UTSW Medical Center at Dallas - Aston Ambulatory Care Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Optive, then Systane Artificial Tears
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.
Geneesmiddel: 1st visit Optive, then 2nd visit Systane

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

Second visit: Instillation of Systane followed by evaporometry assessment after 30 minutes.
Actieve vergelijker: Systane, then Optive Artificial Tears
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.
Geneesmiddel: 1st visit Systane, then 2nd visit Optive

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

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Aqueous Tear Evaporation Rate Before and After Use of OTC Artificial Tears
Tijdsspanne: Baseline and 30 minutes after artificial tear instillation
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Texas Southwestern Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2007

Primaire voltooiing (Werkelijk)

1 maart 2009

Studie voltooiing (Werkelijk)

1 maart 2009

Studieregistratiedata

Eerst ingediend

27 januari 2008

Eerst ingediend dat voldeed aan de QC-criteria

7 februari 2008

Eerst geplaatst (Schatting)

8 februari 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 november 2020

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 092007-002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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