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. 2020 Jun 26;2020(6):CD013333. doi: 10.1002/14651858.CD013333.pub2

Murphy 2018.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: parallel group; multi‐arm
Power/Sample size calculation: NR
Participants Baseline characteristics
Group A: Dr. Organic TTFW
Number of participants: 22
Agemean: 49.6 (SD 17.1) years
Women %: NR
Demodex count per 4 eyelashesmean: 4.9 (range: 0–21)
OSDI scoremean: 27.4 (SD 16.7)
Visual acuity: NR
Number of cylindrical dandruff: NR
Group B: OcuSoft Lid Scrub Plus
Number of participants: 24
Agemean: 49.6 (SD 16.9) years
Women %: NR
Demodex count per 4 eyelashesmean: 3.8 (range: 0–11)
OSDI scoremean: 28.6 (SD 23.6)
Visual acuity: NR
Number of cylindrical dandruff: NR
Group C: BlephEx microblepharoexfoliation device
Number of participants: 23
Agemean: 49.86 (SD 19.7) years
Women %: NR
Demodex count per 4 eyelashesmean: 6.5 (range: 1–25)
OSDI scoremean: 30.1 (SD 19.8)
Visual acuity: NR
Number of cylindrical dandruff: NR
Overall
Number of participants: NR
Age: NR
Women %: NR
Demodex count per 4 eyelashes: NR
OSDI score: NR
Visual acuity: 1.08 (SD 0.26)
Number of cylindrical dandruff: NR
Inclusion criteria: aged > 18 years
Exclusion criteria: ocular surgery in the past 6 months, or undergoing current ophthalmic treatment
Pretreatment: individual groups seemed to be balanced; however, their unorthodox control groups were small and younger than the people within their respective groups.
Interventions Intervention characteristics
Group A: Dr. Organic TTFW
  • Dr. Organic TTFW contains 38% terpinen‐4‐ol, the most active ingredient in TTO shown to be effective at killing Demodex folliculorum in a dose‐dependent manner

  • Frequency (or dosing schedule): daily once at night

  • Concentration: 38% terpinen‐4‐ol


Group B: OcuSoft Lid Scrub Plus
  • The active ingredient in OcuSoft Lid Scrub Plus wipes is 1,2‐octanediol; a substance which has been shown to have pediculicide potential

  • Frequency (or dosing schedule): daily once at night

  • Concentration: 0.5% 1,2‐octanediols


Group C: BlephEx microblepharoexfoliation device
  • BlephEx is a patented hand‐held device, developed for the treatment of ocular surface disorders including blepharitis. The apparatus consists of a hand‐held electromechanical unit and a disposable micro‐sponge inserted in the chuck that spins rapidly to provide debridement and exfoliation at the lash margin.

  • Frequency (or dosing schedule): at baseline visit only

  • Concentration: 0%

Outcomes Mean severity of symptoms score (via modified version of the OSDI dry eye questionnaire); habitual visual acuity (LogMAR); slit lamp exam to assess and grade presence of cylindrical dandruff; and assessment for presence of Demodex.
Identification Sponsorship source: materials used in study supplied by Scope Ophthalmics and Dr. Organic Ltd.
Country: Ireland
Setting: Dublin Institute of Technology
Comments: none
Authors name: Orla Murphy
Institution: Dublin Institute of Technology
Address: NR
Clinical trial registry/registration number: NR
Notes Each of the three arms also includes "control" participants who did not have Demodex follicurlorum
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgment comment: participants were asked to choose a number from a list. Each number corresponded to a treatment.
Allocation concealment (selection bias) Unclear risk Quote: "Each subject chose a number from the list, which corresponded to the treatment assigned to the subject."
Judgment comment: information not provided.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "The examiner was blind to the treatment throughout all stages of the study for group A and group B. The examiner performed the BlephEx™ treatment on subjects from group C and was therefore not blind to the treatment in this group."
Judgment comment: examiner knew who was in 1 of the groups, and the participants knew which group they were in.
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "The examiner performed the BlephEx™ treatment on subjects from group C and was therefore not blind to the treatment in this group."
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgment comment: there is sufficient explanation provided for all analysis. No missing data reported
Selective reporting (reporting bias) Unclear risk Judgment comment: no prepublished protocol listed, so we could not determine if there was selective reporting.