The Effect of Eyelid Margin Debridement on Contact Lens Discomfort
Condition: Contact Lens Discomfort
Study type: Interventional

Summary: 
      In this study, clinical variables related to eyelids that potentially have an effect on
      contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid
      sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of
      this study is to understand the duration of efficacy of debridement of the eyelid margin and
      its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel
      conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions,
      palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties
      (both biophysical properties such as tear volume, tear meniscus height, tear evaporation,
      tear osmolarity and tear breakup time; and biochemical properties that are tear lipid
      analysis). To observe these variables, this study employs a cross-sectional design to study
      the effect of treatment at three instances, that is at baseline and two follow-up visits.
    

Detailed description: 
      Contact lens discomfort (CLD) is a substantial problem experienced frequently by contact lens
      wearers and it is the primary factor associated with permanent discontinuation of lens wear.
      Studies report that between 43% and 72% of contact lens wearer's dropout due to discomfort.
      Reducing the number of contact lens (CL) patient dropouts has been a continuing challenge for
      eye care professionals. With more than 125 million contact lens wearers around the world,
      patient discontinuations can have a considerable economic impact on an eye care practice.

      Definition: Contact lens discomfort is a condition characterized by episodic or persistent
      adverse ocular sensations related to lens wear, either with or without visual disturbance,
      resulting from reduced compatibility between the contact lens and the ocular environment,
      which can lead to decreased wearing time and discontinuation of contact lens wear.

      Inferences from our earlier study (HC15119) showed that eyelid margin debridement
      significantly improves eyelid signs, tear film properties and comfort in contact lens
      wearers. But the previous study did not consider the duration of efficacy as the subjects
      were only followed up once after 7-10days from treatment. Observing subjects more frequently
      will help us understand the duration of efficacy of debridement therapy. Also, the previous
      study did not examine the biochemical changes to tear film lipids that are produced by the
      eyelids.

      It is hypothesized that debridement of eyelid margins improves lipid secretions that then
      help to form a stable lipid layer over ocular surface, thereby improving the tear evaporation
      dynamics and comfort in contact lens wearers.

      Aim: The aim of the study is to observe the duration of efficacy of debridement of the eyelid
      margins in improving secretions from eyelid glands and whether the debridement helps to form
      a stable tear film over ocular surface, thereby improving comfort in contact lens wearers.

      Objectives: To determine the effect of BlephEx - debridement therapy (an in-office eyelid
      treatment) on eyelid signs and secretions, tear film and contact lens discomfort.

      To observe differences in discomfort in contact lens wearers To determine the duration of
      efficacy of BlephEx debridement therapy in contact lens wearers, by following up after 12-15
      days and 22-25days from the baseline (Treatment) visit.

      Methods: The study employs cross-sectional study design, to observe the effect of treatment
      at three instances, one baseline (treatment) visit and two follow-up visits. At the baseline
      visit, informed consent will be obtained from the subjects and assessment of the study
      variables will be performed. Participants will undergo treatment on the same day with
      BlephEx. At baseline, the measurements are performed prior to treatment to record preliminary
      scores and then treatment is performed. Participants are asked to return to the clinic for
      follow-up visits during which no treatment will be performed, but variables are assessed to
      determine the difference from baseline measurements. The 2nd visit will be after 12 -16 days
      after the baseline visit. The last follow-up will be 22-26 days after the baseline visit. All
      study variables will be assessed during all three visits to the clinic.

      Treatment Procedure: BlephEx is an instrument that contains a handpiece used to spin a
      medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf
      and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used
      for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.

      Lid Hygenix is a commercially available formulated hypoallergenic foam cleanser will be used
      to moisten the BlephEx debridement tips.

      Both the products are commercially available. The procedure is safe, painless and regularly
      performed by optometrists.

      'Participant information sheet and informed consent' and 'web-based survey for the end of the
      day discomfort rating' will be sent out in the form of an email. Participants who are
      interested in participation will respond to the survey and results will be used only after
      the subject signs the informed consent in the presence of the investigator, during the
      baseline visit. This survey response will be used as baseline data for the end of the day
      discomfort.
    

Intervention name(s): BlephEx; Lid Hygenix
Intervention type(s): Device; Other
Intervention description(s): BlephEx is an instrument that contains a hand piece used to spin a medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.; Foam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, cross-over, open-label interventional study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eyelid margin; Tear Film; Debridement; Contact Lens; Ocular Discomfort