Evaluation of a New Method for Instilling Eye Drops
Condition: Ophthalmic Solutions; Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this project is to demonstrate that there is a new easier method to instill
      eye drops in ones own eye that is as effective as applying a drop directly to their open eye.
      The benefits of this new method include better medication compliance and reduced patient
      anxiety from instilling their eye drops. This secondary benefit should remove the
      "approach-avoidance response" that prompts some patients to delay or give-up on instilling
      their drops just to avoid the angst and frustration produced by the challenge.

      The new method involves the patient instilling the eye drop onto their closed eyelid and then
      blinking the eye drop into their eye. We aim to show that this method has a similar
      therapeutic effect as the routine administration of an eye drop to an open eye.
    

Detailed description: 
      PURPOSE:

      The purpose of this project is to test an alternative method for instilling eye drops. The
      new method involves the patient self-administer the eye drop onto the skin of their medial
      canthus, with the lids gently closed, and then open the lids once the "cold and wet"
      sensation of the eye drop is felt along the margins of the closed lids. We will compare the
      physiological and therapeutic efficacy of instilling the same eye drops into the eyes of the
      same subjects, using two methods. The first will be to have the eye drop administered using
      the "gold standard" method employed by optometrists to instill eye drops in the office. The
      second will be to employ the new method of self-administration described above.

      HYPOTHESIS:

      Instillation of an eye drop, over the gently closed lids at the medial canthus, has the same
      physiological effect and therapeutic efficacy as a drop of the same agent, at the same
      concentration, properly applied onto an open eye by a trained professional.

      Aim #1: Determine if there is a difference in efficacy between drops of 0.5% timolol maleate
      administered by a professional, using the standard clinical method versus patient
      self-administration using the newly proposed method, in NORMAL SUBJECTS.

      Aim #2: Determine if there is a difference in efficacy between glaucoma drops administered by
      a professional, using the standard method versus with patient self-administration of the same
      drop, using the newly proposed method, in GLAUCOMA PATIENTS.

      JUSTIFICATION:

      While new drug development in the glaucoma field seeks to address the issue of the difficulty
      patients experience with self-administration of an eye drop by pressing for new drugs that
      show efficacy in a once daily dosing routine, this strategy has potentially serious negative
      consequences. Clearly, when glaucoma medications are administered only once a day, if the
      patient misses their eye on that single instillation, the period of lapsed treatment is 24
      hours or more. If their disease worsens, either due to non-compliance with their treatment
      regimen or inability to instill an eye drop, they will require more follow up visits,
      additional medications, additional diagnostic tests, and earlier surgery.

      In this regard, the consequences of non-compliance or inability to comply are the same -
      increased blindness from glaucoma and increased costs associated with trying to prevent this
      blindness in needlessly advancing disease.

      OBJECTIVES:

      The objective of this proposal is to test the therapeutic efficacy of an alternative method
      of instilling eye drops. This requires comparing the effects of the same volume of the same
      drug, applied using the classical method and the new alternative method. If the proposed
      study is successful, a more reliable method for instilling drops of all kinds, to all
      patients, will have been validated.
    

Intervention name(s): Timolol maleate 0.5% ophthalmic solution
Intervention type(s): Drug
Intervention MeSH terms: Timolol; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other