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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682460
First Posted: September 11, 2012
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Waterloo
  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: Intervention Model: Single Group Assignment
Masking: None (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:

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma Tears
Drug Information available for: Tetrahydrozoline hydrochloride Hydroxypropyl methylcellulose Boric acid
U.S. FDA Resources

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Ocular Surface Staining [ Time Frame: At baseline (dispensing visit) ]
    Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence

  • Ocular Surface Staining [ Time Frame: After 1 week ]
    Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence

  • Ocular Surface Staining [ Time Frame: After 1 month ]
    Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence

  • Tear Break up Time With Fluorescein [ Time Frame: At baseline (dispensing visit) ]
    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 .

  • Tear Break up Time With Fluorescein [ Time Frame: After 1 week ]
    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 .

  • Tear Break up Time With Fluorescein [ Time Frame: After 1 month ]
    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) ]
    The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).

  • Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 week after using artificial tears ]
    The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).

  • Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 month after using artificial tears ]
    The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).


Other Outcome Measures:
  • Subjective Ratings of Comfort [ Time Frame: At baseline (dispensing visit) ]
    Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)

  • Subjective Ratings of Comfort [ Time Frame: 1 week after using artificial tears ]
    Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)

  • Subjective Ratings of Comfort [ Time Frame: 1 month after using artificial tears ]
    Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01682460     History of Changes
Other Study ID Numbers: 18262
First Submitted: August 29, 2012
First Posted: September 11, 2012
Results First Submitted: May 14, 2014
Results First Posted: July 3, 2014
Last Update Posted: June 5, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Glaucoma
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Ocular Hypertension
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
 Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents


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