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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:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01682460
First received: August 29, 2012
Last updated: July 2, 2014
Last verified: July 2014
History of Changes
  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:

MedlinePlus related topics: Glaucoma Tears
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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ 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 .

  • 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 .

  • 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) ] [ Designated as safety issue: No ]
    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 to 100.

  • Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 week after using artificial tears ] [ Designated as safety issue: No ]
    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 to 100.

  • Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 month after using artificial tears ] [ Designated as safety issue: No ]
    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 to 100.


Other Outcome Measures:
  • Subjective Ratings of Comfort [ Time Frame: At baseline (dispensing visit) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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
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, see Learn About Clinical Studies.

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
Results First Received: May 14, 2014
Last Updated: July 2, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Ophthalmic Solutions
 Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015