Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients (IVES)

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01682460
First received: August 29, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.


Condition Intervention Phase
Glaucoma
Dry Eyes
Drug: Refresh Tears Lubricant Eye Drops (Allergan)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Ocular surface staining [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]
    Corneal and conjunctival staining will be assessed using slit lamp biomicroscopy.

  • Tear break up time with fluorescein [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]
    The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

  • Ocular surface staining [ Time Frame: After 1 week ] [ Designated as safety issue: No ]
    Corneal and conjunctival staining will be assessed using slit lamp biomicroscopy.

  • Tear break up time with fluorescein [ Time Frame: After 1 week ] [ Designated as safety issue: No ]
    The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

  • Ocular surface staining [ Time Frame: After 1 month ] [ Designated as safety issue: No ]
    Corneal and conjunctival staining will be assessed using slit lamp biomicroscopy.

  • Tear break up time with fluorescein [ Time Frame: After 1 month ] [ Designated as safety issue: No ]
    The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .


Secondary Outcome Measures:
  • Ocular surface disease index (OSDI) score [ Time Frame: At baseline (dispensing visit) and 1 week and 1 month after using artificial tears ] [ Designated as safety issue: No ]
    Participants will complete a standardized questionnaire regarding their symptoms of dry eyes and comparisons will be made between the scores after 1 week and 1 month of artificial tear use with the baseline score.


Other Outcome Measures:
  • Subjective ratings of comfort, dryness, burning and redness [ Time Frame: At baseline (dispensing visit) and 1 week and 1 month after using artificial tears ] [ Designated as safety issue: No ]
    Participants will complete a standardized grading scales regarding their subjective ratings of comfort, dryness, burning and redness and comparisons will be made between the scores after 1 week and 1 month of artificial tear use with the baseline score.


Enrollment: 15
Study Start Date: August 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Refresh Tears Lubricant Eye Drops (Allergan)
Artificial tears eye drops QID for 1 month
Drug: Refresh Tears Lubricant Eye Drops (Allergan)
Eye drops QID for 1 month

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a current non-contact lens wearer.
  • Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.
  • The glaucoma medication dosage and usage must have been the same for >6 months.
  • Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.
  • Distance VA of at least 20/40 in each eye with current spectacle correction.

Exclusion Criteria:

  • Is participating in any concurrent clinical or research study;
  • Has any known active* ocular disease and/or infection; except primary open angle glaucoma.
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery;
  • Is an employee of the Centre for Contact Lens Research;
  • Has taken part in another (pharmaceutical) research study within the last 30 days;
  • Is currently using artificial tears more than 3 times per day.

    • For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682460

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Allergan
Investigators
Principal Investigator: Lyndon Jones, PhD University of Waterloo
  More Information

No publications provided

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01682460     History of Changes
Other Study ID Numbers: 18262
Study First Received: August 29, 2012
Last Updated: April 23, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Glaucoma
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ocular Hypertension
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014