Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

NCT04204954 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 201959B1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Demodex Infestation; Demodicosis; Cataract

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Endophthalmitis in the postoperative period.

  One week.

Study Arms (4)

Group 1: Topical 0.3% Ciprofloxacin [Cipro]

OTHER

Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days.

Drug: Ciprofloxacin Ophthalmic Ointment 0.3%

Group 2: Cipro + 50% diluted baby shampoo

ACTIVE COMPARATOR

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%; Other: Baby shampoo

Group 3: Cipro + Blephaclean

ACTIVE COMPARATOR

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%; Other: Blephaclean

Group 4: Cipro + Tea tree oil.

EXPERIMENTAL

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.

Other: Tea Tree Oil Shampoo; Drug: Ciprofloxacin Ophthalmic Ointment 0.3%

Interventions

Tea Tree Oil Shampoo OTHER

Twice a day eyelid margin cleansing for three days.

Group 4: Cipro + Tea tree oil.

Ciprofloxacin Ophthalmic Ointment 0.3% DRUG

Applied topically in the eyelid margin every four hours for three days.

Group 1: Topical 0.3% Ciprofloxacin [Cipro]; Group 2: Cipro + 50% diluted baby shampoo; Group 3: Cipro + Blephaclean; Group 4: Cipro + Tea tree oil.

Baby shampoo OTHER

Twice a day eyelid margin cleansing for three days.

Also known as: 50% diluted baby shampoo

Group 2: Cipro + 50% diluted baby shampoo

Blephaclean OTHER

Twice a day eyelid margin cleansing for three days.

Group 3: Cipro + Blephaclean

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Luz

Mexico City, 06030, Mexico

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Claudia Palacio Pastrana, M.D., M.P.H.

  Hospital de La Luz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcomes assessors were blinded to the treatment allocation of each participant. Outcome assessors were anterior segment surgeons who evaluated cases prior to cataract surgery. There was no indication of group allocation in the electronic medical records (EMR), only the participation of each candidate in the study. Similarly, investigators were blinded to group allocation and only recorded data directly from EMR. Blinding was kept after data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients diagnosed with Demodex spp. infestation undergoing cataract surgery were randomly allocated into four comparison groups a control group (standard treatment) and three new modalities of Demodex therapy (Blephaclean, baby shampoo, and tea tree oil) + conventional treatment.

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 19, 2019
• Study Start: May 6, 2019
• Primary Completion: November 14, 2019
• Study Completion: December 13, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)