Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

A Randomized Controlled Trial of Treatment Efficacy in Ameliorating Demodex Spp. Infestation Among Cases Undergoing Cataract Surgery

Demodex blepharitis is a prevalent cause of comorbid infection among individuals undergoing cataract surgery. Several complications may arise in the postsurgical period from Staphylococcus or Streptococcus co-infections, as Demodex is a vector for these pathogens. Hence, prophylactic treatments before cataract surgery may lead to a reduction in complication rates. Since Demodex infestation and cataract surgery are two prevalent coexisting conditions in the general population, this study aims to test the effect of four combined treatments to eradicate or improve the Demodex infestation index before surgery. The investigators are conducting a single-blinded randomized trial of four therapies in participants undergoing cataract surgery. All participants will or are receiving daily eyelid cleansing bid and topical 0.3% ciprofloxacin q4h for three days added to the allocated treatment arm. Our four intervention groups are: [1] Blephaclean eye scrubs; [2] 50% dilution baby shampoo; [3] tea tree oil shampoo; [4]: topical 0.3% ciprofloxacin alone. To assess treatment efficacy, the investigators will perform eyelash hair epilation pre and postoperatively. The primary outcome is a change in the mean Demodex spp. infestation index. Also, a change in the crude number of Demodex (egg, larvae, nymph, or adult-form) spp. in eyelashes after one-week of therapy.

Study Overview

• Status: Completed
• Conditions: Cataract; Demodex Infestation; Demodicosis
• Intervention / Treatment: Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Other: Baby shampoo; Other: Blephaclean; Other: Tea Tree Oil Shampoo

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06030
    • Hospital de La Luz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent after explanation of the nature and possible consequences of the study.
• Clinical diagnosis of cataracts staged with Lens Opacity Classification System III based on the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery guidelines.
• No topical antibiotic ointment therapy or eyelid cleansing in the past six months.
• No systemic antibiotic or antiparasite treatment in the past six months.
• No ocular comorbidities (other than cataracts)
• No systemic comorbidities.

Exclusion Criteria:

• Withdrawal from the study.
• Minimal changes based on the Lens Opacity Classification System III.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: Topical 0.3% Ciprofloxacin [Cipro]; Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days.	Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Applied topically in the eyelid margin every four hours for three days.
Active Comparator: Group 2: Cipro + 50% diluted baby shampoo; Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with 50% diluted baby shampoo for three days.	Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Applied topically in the eyelid margin every four hours for three days.; Other: Baby shampoo; Twice a day eyelid margin cleansing for three days.; Other Names: 50% diluted baby shampoo
Active Comparator: Group 3: Cipro + Blephaclean; Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with Blephaclean Sterile Eyelid Wipes (Thea Pharmaceuticals) for three days.	Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Applied topically in the eyelid margin every four hours for three days.; Other: Blephaclean; Twice a day eyelid margin cleansing for three days.
Experimental: Group 4: Cipro + Tea tree oil.; Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with tea tree oil shampoo for three days.	Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Applied topically in the eyelid margin every four hours for three days.; Other: Tea Tree Oil Shampoo; Twice a day eyelid margin cleansing for three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Demodex spp. infestation index by intervention group	Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).	One week.
Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group	Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation).	One week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endophthalmitis in the postoperative period.	Number of cases diagnosed with endophthalmitis in the postoperative period.	One week.

Collaborators and Investigators

• Sponsor: Hospital de La Luz
• Collaborators: Claudia Palacio Pastrana, M.D., M.Sc.; Samuel J. Avalos Lara, M.D.; Hector Perez Cano, Ph.D.; Bani Antonio-Aguirre, M.D., M.P.H.c.; Cristina Mendoza-Velasquez, M.D., M.Sc.; Azyadeh Camacho-Ordóñez, M.D., M.Sc.c.; Andric C. Perez-Ortiz, M.D., M.P.H.
• Investigators: Principal Investigator: Claudia Palacio Pastrana, M.D., M.P.H., Hospital de La Luz

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): November 14, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Lens Diseases; Cataract; Parasitic Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Tea Tree Oil; Ciprofloxacin
• Other Study ID Numbers: 201959B1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes