Systane Ultra Versus Maxidex Versus Saline

January 22, 2013 updated by: Penny Asbell, Icahn School of Medicine at Mount Sinai

Study to Evaluate the Ocular Surface Healing Action of the Artificial Tear Systane ULTRA Using Both Positive (Maxidex) and Negative (Saline Solution) Controls

This study was to evaluate the healing action on the eye surface of the artificial tear Systane® ULTRA as compared to two other eyedrops: Maxidex and Saline solution. Dry eye disease leads to inflammation of the eye surface and treating dry eyes with artificial tears may lead to reduction in this inflammation and improvement of symptoms and signs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For all patients who present to the office with a history of dry eyes:

  1. Consent forms will be obtained from every patient. Informed consent will be discussed with the patient in detail. Every topic will be addressed separately. All risks, benefits, and alternatives will be discussed. Patient will be allowed to ask questions, and all questions will be answered. The assessment will be made after that conversation, whether or not the patient understood the consent as described above. Each subject will be allowed as much time as needed to review and sign the consent forms.
  2. All patients will be asked to fill out the Ocular Surface Discomfort Index (OSDI) questionnaire to ensure they meet the inclusion criteria. If patients score meets eligibility requirements a general and ocular history will be taken. (Time: 10 min)
  3. A pregnancy test will be given to all female subjects of child bearing age. A standard eye exam will be performed to rule out any other ocular pathology besides refractive error. This allows for confirmation that all study subjects have dry eye disease. Topical fluorescein and lissamine dye will be used to record staining on the cornea and conjunctiva of subjects as well as the tear film break-up time (TFBUT). Both of these dyes are used as standard-of-care in eye exams around the country. TFBUT will first be determined through application of sodium fluorescein onto the eye using DET strip. Following triplicate evaluation of TFBUT in each eye, ocular staining will be determined with liquid fluorescein and lissamine dyes administered in liquid form. (Time 15 min).
  4. Patients will be given Alcon questionnaires to fill out, inquiring about past treatments, daily symptoms and distress associated with their dry eye disease. (Time:15 minutes) This also serves as a waiting period for some of the dye to wash out.
  5. Using a graduated disposable 5 µl microcapillary tube (Wiretol-Micropipettes, Drummond Scientific Co., Broomall, PA, USA) up to 5 µl of tears / eye will be collected from the inferior temporal tear meniscus of each participant, without corneal anesthesia, taking care to ensure that the lid margin and corneal surface were not touched. A maximum of 5 minutes will be allowed per eye for collection of minimal 5 uL of tear. Tears will be immediately dispensed into pre-labeled Eppendorf tubes and placed on dry ice until transferred to -80oC for storage. (Time: 10 minutes)
  6. A technique known as Impression Cytology (IC) will be used to isolate epithelial cells from the conjunctiva. Anesthetic drops will be administered to each eye before the procedure. Blunted forceps are used to gently press a piece of filter paper against the patient's conjunctiva. The paper is gently lifted off, and sent to the Mount Sinai Laboratory for analyses. (Estimated collection time: 15 minutes). A total of 6 pieces per patient (3 pieces per eye) will be collected on each scheduled visit. For HLA-DR analysis, 2 pieces from each eye will be held at room temperature in a vial containing fixative until assay. The remaining 1 piece from each eye will be pooled together in one vial for RT-PCR assays in the following order: (1) immediately merged into a pre-labeled Eppendorf tube with 600 µL of TriZol Reagent; (2) Vortex for 30 seconds; (3) sealed with Saran Wrap; (4) transfer to -80C for storage until assay.
  7. Measurement of Intraocular pressure using Tonopen.
  8. As a part of the substudy we intend to treat patients with Systane ULTRA®, Maxidex, (both of which are FDA approved ophthalmic solutions), or the saline solution placebo. Subjects will be assigned to one of the three groups as per randomization sequence and the corresponding eye drop will be dispensed.
  9. The patient's response to treatment will be assessed after approximately 4 weeks (+/- 5 days) using the same diagnostic tests in order to assess the sensitivity of these diagnostic tests to detect the response to medical treatment of dry eye disease. In addition to baseline and 4 week visits, safety evaluations will be performed at a 2 week (+/- 5 days) visit. All the procedures done during the baseline visit will be repeated except pregnancy test, tear collection and impression cytology.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A score of at least 15 on the Ocular Surface Discomfort Index (OSDI) symptom questionnaire.
  • Moderate vital staining, fluorescein (for corneal evaluation, 3-15 on the NEI scale) OR lissamine (for conjunctival evaluation, score of 2-6; temporal and nasal areas, each graded 0-3).
  • Willingness to use study drugs 4 times per day in both eyes.
  • Willingness to discontinue use of other artificial tear products.
  • Patient must provide written informed consent
  • Patient must understand the scope of the study including completion of worksheet and be willing to follow instructions and return for all required study visits
  • An intraocular pressure less than or equal to 22 mmHg in both eyes

Exclusion Criteria:

  • Contact Lens wearers
  • Pregnant and/or lactating women
  • Those with moderate to severe Meibomian Gland Disease i.e. plugging of 3 or more glands and/or pasty secretion from 3 or more glands or presence of obstructed glands out of a total of 10 glands evaluated in the central portion of the lower lid.
  • Uncontrolled systemic or ocular disease
  • Dry eye due to seasonal allergic conjunctivitis, contact lens related conjunctivitis or other acute or seasonal diagnosis.
  • Are monocular and/or legally blind
  • Had ocular surgery or trauma within last six months
  • Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
  • Current use of any eye drops other than artificial tears
  • Use of Restasis within three months prior to entry in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Systane Ultra
Artificial tear Eyedrop, 1 drop used four times a day (QID) for 4 weeks
Drug: Systane Ultra
Artificial tear Eyedrop, 1 drop used QID for 4 weeks
Other Names:
  • Artificial Tears
Placebo Comparator: Saline solution
Saline solution Eyedrop, 1 drop used QID for 4 weeks
Drug: Saline solution
Saline solution,1 drop used QID for 4 weeks
Active Comparator: Maxidex
Steroid eyedrop, 1 drop QID for 4 weeks
Drug: Maxidex
Eyedrop-1 drop QID for 4 weeks
Other Names:
  • Dexamethasone 0.1% eyedrop

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OSDI score
Time Frame: at Baseline
questionnaire pertaining to dry eye symptoms answered by patients
at Baseline
OSDI score
Time Frame: visit 2 (at 2 weeks)
questionnaire pertaining to dry eye symptoms answered by patients
visit 2 (at 2 weeks)
OSDI score
Time Frame: at visit 3 (at 4 weeks)
questionnaire pertaining to dry eye symptoms answered by patients
at visit 3 (at 4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tear Film break up time
Time Frame: at Baseline
Time taken for the first dry spot to appear in the tear film
at Baseline
Tear Film break up time
Time Frame: at visit 2 (at 2 weeks)
Time taken for the first dry spot to appear in the tear film
at visit 2 (at 2 weeks)
Tear Film break up time
Time Frame: at visit 3 (at 4 weeks)
Time taken for the first dry spot to appear in the tear film
at visit 3 (at 4 weeks)
Corneal Staining
Time Frame: at Baseline
Grading of fluorescein staining of the cornea using a slit lamp and NEI grading scale
at Baseline
Corneal Staining
Time Frame: at visit 2 (at 2 weeks)
Grading of fluorescein staining of the cornea using a slit lamp and NEI grading scale
at visit 2 (at 2 weeks)
Corneal Staining
Time Frame: at visit 3 (at 4 weeks)
Grading of fluorescein staining of the cornea using a slit lamp and NEI grading scale
at visit 3 (at 4 weeks)
Conjunctival Staining
Time Frame: at Baseline
Grading of Lissamine green staining of the conjunctiva using a slit lamp and NEI grading scale
at Baseline
Conjunctival Staining
Time Frame: at visit 2 (at 2 weeks)
Grading of Lissamine green staining of the conjunctiva using a slit lamp and NEI grading scale
at visit 2 (at 2 weeks)
Conjunctival Staining
Time Frame: at visit 3 (at 4 weeks)
Grading of Lissamine green staining of the conjunctiva using a slit lamp and NEI grading scale
at visit 3 (at 4 weeks)
Best corrected visual acuity
Time Frame: at Baseline
BSCVA using ETDRS charts
at Baseline
Best corrected visual acuity
Time Frame: at visit 2 (at 2 weeks)
BSCVA using ETDRS charts
at visit 2 (at 2 weeks)
Best corrected visual acuity
Time Frame: at visit 3 (at 4 weeks)
BSCVA using ETDRS charts
at visit 3 (at 4 weeks)
Tear Cytokines
Time Frame: At baseline
Tear samples collected from both eyes using microcapillary tube. Samples analysed for inflammatory cytokines using Luminex bioassays
At baseline
Tear Cytokines
Time Frame: At visit 3 (at 4 weeks)
Tear samples collected from both eyes using microcapillary tube. Samples analysed for inflammatory cytokines using Luminex bioassays
At visit 3 (at 4 weeks)
mRNA for HLA-DR
Time Frame: At baseline
Cell samples collected via impression cytology and analysed for mRNA expression via flowcytometer
At baseline
mRNA for HLA-DR
Time Frame: At visit 3 (at 4 weeks)
Cell samples collected via impression cytology and analysed for mRNA expression via flowcytometer
At visit 3 (at 4 weeks)
HLA-DR expression
Time Frame: At baseline
Cell samples collected via impression cytology and analysed for HLA-DR expression via flowcytometer
At baseline
HLA-DR expression
Time Frame: At visit 3 (at 4 weeks)
Cell samples collected via impression cytology and analysed for HLA-DR expression via flowcytometer
At visit 3 (at 4 weeks)
IDEEL questionnaire
Time Frame: At baseline
questionnaire pertaining to dry eye symptoms, quality of life, and treatment answered by patients
At baseline
IDEEL questionnaire
Time Frame: At visit 2 (at 2 weeks)
questionnaire pertaining to dry eye symptoms, quality of life, and treatment answered by patients
At visit 2 (at 2 weeks)
IDEEL questionnaire
Time Frame: At visit 3 (at 4 weeks)
questionnaire pertaining to dry eye symptoms, quality of life, and treatment answered by patients
At visit 3 (at 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Penny Asbell, MD, MBA, FACS, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 11-1230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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