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Completed

NCT Number: NCT01682460

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

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.

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Key information

Conditions

Glaucoma Dry Eye Syndromes Dry Eyes Eye Diseases Lacrimal Apparatus Diseases Ocular Hypertension

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Refresh Tears Lubricant Eye Drops (Allergan)

Drug

Eye drops QID for 1 month

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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 .

  5. 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 .

  6. 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 outcomes

  1. 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).

  2. 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).

  3. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Allergan

Registry information

Acronym: IVES

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2012
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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