NCT03422146.

Study name	Antimicrobial and clinical efficacy of Cliradex® as compared with I‐Lid'n Lash® hygiene in treating blepharitis
Methods	Study design: randomized controlled trial Study grouping: parallel group
Participants	Baseline characteristics I‐Lid 'n Lash® Hygiene control group Number of participants: NR Age: NR Women %: NR Demodex count per eyelash: NR OSDI score: NR Visual acuity: NR Number of cylindrical dandruff: NR Cliradex® eyelid hygiene (intervention) group Number of participants: NR Age: NR Women %: NR Demodex count per eyelash: NR OSDI score: NR Visual acuity: NR Number of cylindrical dandruff: NR Overall Number of participants: NR Age: NR Women %: NR Demodex count per eyelash: NR OSDI score: NR Visual acuity: NR Number of cylindrical dandruff: NR Inclusion criteria: symptomatic blepharitis for ≥ 3 months. Men and women aged > 18 years; ethnic groups comparable with the local community; able and willing to co‐operate with the investigational plan; able and willing to complete all postoperative follow‐up visits; able to understand and willing to sign a written informed consent. Exclusion criteria: currently engaged in another clinical trial; unwilling or unable to give consent; unwilling to accept randomization; unable to return for scheduled visits; children aged < 18 years; concomitant use of ophthalmic topical medications (excluding non‐preserved tear substitutes); concomitant use of systemic antibiotics or steroids; active ocular infection or allergy; previous surgery on the eyelids such as blepharoplasty; abraded skin on or around the eyelids; unable to close eyes or uncontrolled blinking; previous allergic reaction to TTO‐containing products or cosmetic fragrance. Pretreatment: unable to determine from the registration. This study is still recruiting.
Interventions	Intervention characteristics I‐Lid 'n Lash Hygiene control group Lid 'n Lash Hygiene, a non‐prescription eyelid wipe, without any medicinal ingredients Frequency (or dosing schedule): twice a day for 2 weeks Concentration: NR Cliradex eyelid hygiene (intervention) group Cliradex, a non‐prescription eyelid wipe that contains the most active ingredient of TTO. Frequency (or dosing schedule): twice a day for 2 weeks Concentration: NR
Outcomes	Primary: change in the number of colony‐forming units after 2 weeks' treatment Secondary: improvement in signs and symptoms of blepharitis Other: evidence of continued microbiologic improvement after discontinuing blepharitis treatment; evidence of continued improvement in signs and symptoms of blepharitis, based on grading scale, after discontinuing blepharitis treatment; evidence of continued improvement in signs and symptoms of blepharitis, based on participant questionnaire, after discontinuing blepharitis treatment.
Starting date	February, 2017
Contact information	clinicaltrials.gov/show/nct03422146
Notes

NR: not reported; OSDI: Ocular Surface Disease Index; TTO: tea tree oil.