NCT01775540

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

December 7, 2012

Last Update Submit

January 22, 2013

Conditions

Dry Eye Disease

Keywords

Dry eyeArtificial tearsOcular surface inflammation

Outcome Measures

Primary Outcomes (3)

  • OSDI score

    questionnaire pertaining to dry eye symptoms answered by patients

    at Baseline

  • OSDI score

    questionnaire pertaining to dry eye symptoms answered by patients

    visit 2 (at 2 weeks)

  • OSDI score

    questionnaire pertaining to dry eye symptoms answered by patients

    at visit 3 (at 4 weeks)

Secondary Outcomes (21)

  • Tear Film break up time

    at Baseline

  • Tear Film break up time

    at visit 2 (at 2 weeks)

  • Tear Film break up time

    at visit 3 (at 4 weeks)

  • Corneal Staining

    at Baseline

  • Corneal Staining

    at visit 2 (at 2 weeks)

  • +16 more secondary outcomes

Study Arms (3)

Systane Ultra

EXPERIMENTAL

Artificial tear Eyedrop, 1 drop used four times a day (QID) for 4 weeks

Drug: Systane Ultra

Saline solution

PLACEBO COMPARATOR

Saline solution Eyedrop, 1 drop used QID for 4 weeks

Drug: Saline solution

Maxidex

ACTIVE COMPARATOR

Steroid eyedrop, 1 drop QID for 4 weeks

Drug: Maxidex

Interventions

Systane UltraDRUG

Artificial tear Eyedrop, 1 drop used QID for 4 weeks

Also known as: Artificial Tears
Systane Ultra
Saline solutionDRUG

Saline solution,1 drop used QID for 4 weeks

Saline solution
MaxidexDRUG

Eyedrop-1 drop QID for 4 weeks

Also known as: Dexamethasone 0.1% eyedrop
Maxidex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye DropsSaline SolutionDexamethasoneOphthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of ChemicalsCrystalloid SolutionsIsotonic SolutionsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Penny Asbell, MD, MBA, FACS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2012

First Posted

January 25, 2013

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)