Treatment of Blepharitis Induced by Demodex Folliculorum Through Eyelid Cleansing With Wipes Containing Topical Chlorhexidine

NCT07451678 | Completed Phase 4 DMC

• 1 other identifier: CEI-2024/06/07
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This study employed an experimental, prospective, longitudinal, before-and-after design to evaluate the efficacy of topical chlorhexidine wipes in treating blepharitis. The investigation focused on assessing signs and symptoms associated with Demodex Folliculorum blepharitis, including telangiectasia, ocular irritation, collarettes, foreign body sensation, tearing, eyelid erythema, and dry eye. Each subject underwent an assessment of the Demodex Folliculorum infection index through the epilation of four eyelashes, followed by direct visualization using optical microscopy. Additionally, the number of eyelashes with collarettes was categorized and graded as follows: Grade 0: 0-2 eyelashes per eyelid with collarettes; Grade 1: 3-10 eyelashes per eyelid with collarettes; Grade 2: ≥10 to ≤1/3; Grade 3: ≥1/3 - ≤2/3; Grade 4: ≥2/3 of eyelashes per eyelid with collarettes. Participants applied topical chlorhexidine wipes twice daily, in the morning and evening, to cleanse the eyelash area of both eyelids over a period of four weeks. A follow-up assessment was conducted at four weeks, during which another Demodex test was performed to ascertain the presence of the microorganism. At week ten, the same signs and symptoms evaluated in the initial assessment were re-evaluated for follow-up.

Conditions

Blepharitis

Keywords

Demodex; Blepharitis Drug Therapy; Anti-Infective Agents

Outcome Measures

Primary Outcomes (1)

• Reduction in Demodex folliculorum count per eyelash

  Mean number of Demodex folliculorum mites per eyelash (mites/lash) assessed by epilation of 4 eyelashes from the upper eyelid and 4 eyelashes from the lower eyelid and examination under light microscopy at 40× magnification. The outcome will be reported as the change in mean mites/lash from baseline to 8 weeks after treatment with chlorhexidine eyelid wipes.

  Baseline and 8 weeks

Secondary Outcomes (2)

• Change in eyelash collarette grade

  Baseline and 8 weeks

• Proportion of participants by Ocular Surface Disease Index (OSDI) severity category

  Baseline and 8 weeks

Study Arms (1)

Treatment of Blepharitis by Demodex Folliculorum Group

EXPERIMENTAL

The investigation focused on assessing signs and symptoms associated with Demodex Folliculorum blepharitis, including telangiectasia, ocular irritation, collarettes, foreign body sensation, tearing, eyelid erythema, and dry eye.

Drug: Eyelid Cleansing with Wipes Containing Topical Chlorhexidine

Interventions

Eyelid Cleansing with Wipes Containing Topical Chlorhexidine DRUG

Participants applied topical chlorhexidine wipes twice daily, in the morning and evening, to cleanse the eyelash area of both eyelids over a period of four weeks. A follow-up assessment was conducted at four weeks, during which another Demodex test was performed to ascertain the presence of the microorganism. At week ten, the same signs and symptoms evaluated in the initial assessment were re-evaluated for follow-up.

Treatment of Blepharitis by Demodex Folliculorum Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Clinical diagnosis of Demodex folliculorum blepharitis
• Presence of eyelash collarettes on slit-lamp examination
• Positive identification of Demodex folliculorum by epilation of 4 upper and 4 lower eyelashes per eyelid and visualization under light microscopy
• Willingness to use chlorhexidine eyelid wipes as instructed for 8 weeks

You may not qualify if:

• Use of topical or systemic antiparasitic treatment within the past 6 weeks
• Use of topical ophthalmic antibiotics or anti-inflammatory medication within the past 6 weeks
• Known allergy or hypersensitivity to chlorhexidine
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Mexico City, Mexico City, 06800, Mexico

Location

Related Publications (18)

• Steinsapir KD, Woodward JA. Chlorhexidine Keratitis: Safety of Chlorhexidine as a Facial Antiseptic. Dermatol Surg. 2017 Jan;43(1):1-6. doi: 10.1097/DSS.0000000000000822.

  PMID: 27399954 RESULT

• Cheng SN, Jiang FG, Chen H, Gao H, Huang YK. Intense Pulsed Light Therapy for Patients with Meibomian Gland Dysfunction and Ocular Demodex Infestation. Curr Med Sci. 2019 Oct;39(5):800-809. doi: 10.1007/s11596-019-2108-1. Epub 2019 Oct 14.

  PMID: 31612399 RESULT

• Gaddie IB, Donnenfeld ED, Karpecki P, Vollmer P, Berdy GJ, Peterson JD, Simmons B, Edell ARP, Whitson WE, Ciolino JB, Baba SN, Holdbrook M, Trevejo J, Meyer J, Yeu E; Saturn-2 Study Group. Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2). Ophthalmology. 2023 Oct;130(10):1015-1023. doi: 10.1016/j.ophtha.2023.05.030. Epub 2023 Jun 5.

  PMID: 37285925 RESULT

• Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10.

  PMID: 35965392 RESULT

• Cheung IMY, Xue AL, Kim A, Ammundsen K, Wang MTM, Craig JP. In vitro anti-demodectic effects and terpinen-4-ol content of commercial eyelid cleansers. Cont Lens Anterior Eye. 2018 Dec;41(6):513-517. doi: 10.1016/j.clae.2018.08.003. Epub 2018 Aug 14.

  PMID: 30120003 RESULT

• Savla K, Le JT, Pucker AD. Tea tree oil for Demodex blepharitis. Cochrane Database Syst Rev. 2020 Jun 20;6(6):CD013333. doi: 10.1002/14651858.CD013333.pub2.

  PMID: 32589270 RESULT

• Martinez-Pulgarin DF, Avila MY, Rodriguez-Morales AJ. Interventions for Demodex blepharitis and their effectiveness: A systematic review and meta-analysis. Cont Lens Anterior Eye. 2021 Dec;44(6):101453. doi: 10.1016/j.clae.2021.101453. Epub 2021 May 7.

  PMID: 33972176 RESULT

• Farid M, Ayres BD, Donnenfeld E, Gaddie IB, Gupta PK, Holland E, Lindstrom R, Pflugfelder SC, Karpecki PM, Nichols KK, Starr CE, Yeu E. Delphi Panel Consensus Regarding Current Clinical Practice Management Options for Demodex blepharitis. Clin Ophthalmol. 2023 Feb 27;17:667-679. doi: 10.2147/OPTH.S399989. eCollection 2023.

  PMID: 36875531 RESULT

• Rhee MK, Yeu E, Barnett M, Rapuano CJ, Dhaliwal DK, Nichols KK, Karpecki P, Mah FS, Chan A, Mun J, Gaddie IB. Demodex Blepharitis: A Comprehensive Review of the Disease, Current Management, and Emerging Therapies. Eye Contact Lens. 2023 Aug 1;49(8):311-318. doi: 10.1097/ICL.0000000000001003. Epub 2023 Jun 2.

  PMID: 37272680 RESULT

• Hirsch-Hoffmann S, Kaufmann C, Banninger PB, Thiel MA. Treatment options for demodex blepharitis: patient choice and efficacy. Klin Monbl Augenheilkd. 2015 Apr;232(4):384-7. doi: 10.1055/s-0035-1545780. Epub 2015 Apr 22.

  PMID: 25902082 RESULT

• Shah PP, Stein RL, Perry HD. Update on the Management of Demodex Blepharitis. Cornea. 2022 Aug 1;41(8):934-939. doi: 10.1097/ICO.0000000000002911. Epub 2021 Nov 3.

  PMID: 34743107 RESULT

• Muntz A, Purslow C, Wolffsohn JS, Craig JP. Improved Demodex diagnosis in the clinical setting using a novel in situ technique. Cont Lens Anterior Eye. 2020 Aug;43(4):345-349. doi: 10.1016/j.clae.2019.11.009. Epub 2019 Dec 3.

  PMID: 31806355 RESULT

• Hom MM, Mastrota KM, Schachter SE. Demodex. Optom Vis Sci. 2013 Jul;90(7):e198-205. doi: 10.1097/OPX.0b013e3182968c77.

  PMID: 23748846 RESULT

• Luo X, Li J, Chen C, Tseng S, Liang L. Ocular Demodicosis as a Potential Cause of Ocular Surface Inflammation. Cornea. 2017 Nov;36 Suppl 1(Suppl 1):S9-S14. doi: 10.1097/ICO.0000000000001361.

  PMID: 28902017 RESULT

• Murphy O, O' Dwyer V, Lloyd-McKernan A. The Clinical Use of Eyelash Manipulation in the Diagnosis of Demodex folliculorum Blepharitis. Eye Contact Lens. 2020 Jan;46 Suppl 1:S33-S38. doi: 10.1097/ICL.0000000000000608.

  PMID: 30950926 RESULT

• Liu J, Sheha H, Tseng SC. Pathogenic role of Demodex mites in blepharitis. Curr Opin Allergy Clin Immunol. 2010 Oct;10(5):505-10. doi: 10.1097/ACI.0b013e32833df9f4.

  PMID: 20689407 RESULT

• Rather PA, Hassan I. Human demodex mite: the versatile mite of dermatological importance. Indian J Dermatol. 2014 Jan;59(1):60-6. doi: 10.4103/0019-5154.123498.

  PMID: 24470662 RESULT

• Bitton E, Aumond S. Demodex and eye disease: a review. Clin Exp Optom. 2021 Apr;104(3):285-294. doi: 10.1111/cxo.13123. Epub 2021 Apr 1.

  PMID: 32885484 RESULT

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 5, 2026
• Study Start: July 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 31, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2026

Locations

ME (1)