Demodex InfestationPhase 2/3NCT04204954
Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery
A Phase 2/3 study testing Ciprofloxacin Ophthalmic Ointment 0.3% and Blephaclean in people with Demodex Infestation and Demodicosis, run by Hospital de La Luz at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Demodex Infestation, Demodicosis, Cataract
- What is being tested?
- Ciprofloxacin Ophthalmic Ointment 0.3% and Blephaclean
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- 6 May 2019to 13 Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Withdrawal from the study.
- Minimal changes based on the Lens Opacity Classification System III.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Demodex Infestation, Demodicosis, Cataract
- Being tested
- Tea Tree Oil Shampoo, Ciprofloxacin Ophthalmic Ointment 0.3%, Baby shampoo, Blephaclean
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea Tree Oil ShampooOther
Twice a day eyelid margin cleansing for three days.
Ciprofloxacin Ophthalmic Ointment 0.3%Drug
Applied topically in the eyelid margin every four hours for three days.
Baby shampooOther
Also called 50% diluted baby shampoo
Twice a day eyelid margin cleansing for three days.
BlephacleanOther
Twice a day eyelid margin cleansing for three days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Topical 0.3% Ciprofloxacin [Cipro] | Other | Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Tea Tree Oil Shampoo; Drug: Ciprofloxacin Ophthalmic Ointment 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Demodex spp. infestation index by intervention group
Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).
Measured: 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).
Measured: One week.
Secondary outcomes (1)
Endophthalmitis in the postoperative period.
Number of cases diagnosed with endophthalmitis in the postoperative period.
Measured: One week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start6 May 2019
- Primary completion14 Nov 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demodex InfestationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de La Luz
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Principal investigator, Andric C Perez-Ortiz, M.D., M.P.H., Hospital de La Luz
- Investigators
- Claudia Palacio Pastrana, M.D., M.P.H., Principal investigator, Hospital de La Luz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204954
- Sponsor's protocol ID
- 201959B1
- Status last verified
- Apr 2020
- First submitted
- 14 Dec 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Treatment Efficacy in Ameliorating Demodex Spp. Infestation Among Cases Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT04204954
- Acronym / sponsor ID
- 201959B1
- Conditions
- Demodex Infestation, Demodicosis, Cataract
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospital de La LuzUniversity, hospital or other
- 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.
- Study start
- 6 May 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Topical 0.3% Ciprofloxacin [Cipro] | Other | Drug: Ciprofloxacin Ophthalmic Ointment 0.3%Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. |
| Group 2: Cipro + 50% diluted baby shampoo | Active comparator | Drug: Ciprofloxacin Ophthalmic Ointment 0.3%, Other: Baby shampooCiprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with 50% diluted baby shampoo for three days. |
| Group 3: Cipro + Blephaclean | Active comparator | Drug: Ciprofloxacin Ophthalmic Ointment 0.3%, Other: BlephacleanCiprofloxacin 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. |
| Group 4: Cipro + Tea tree oil. | Experimental | Other: Tea Tree Oil Shampoo, Drug: Ciprofloxacin Ophthalmic Ointment 0.3%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Withdrawal from the study.
- Minimal changes based on the Lens Opacity Classification System III.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tea Tree Oil ShampooTwice a day eyelid margin cleansing for three days. | Other | Group 4: Cipro + Tea tree oil. |
| Ciprofloxacin Ophthalmic Ointment 0.3%Applied topically in the eyelid margin every four hours for three days. | Drug | 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 shampooAlso: 50% diluted baby shampooTwice a day eyelid margin cleansing for three days. | Other | Group 2: Cipro + 50% diluted baby shampoo |
| BlephacleanTwice a day eyelid margin cleansing for three days. | Other | Group 3: Cipro + Blephaclean |
Primary outcome
Mean Demodex spp. infestation index by intervention group
Time frame: One week.
Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).
Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group
Time frame: One week.
Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation).
1 secondary outcome
Endophthalmitis in the postoperative period.
Time frame: One week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Demodex Infestation
Not yet recruitingObservational study
Demodex Mites in Acne Patients and Herbal Extract Susceptibility
Acne, Demodex Infestation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Palacio Pastrana, M.D., M.P.H. principal investigator
Hospital de La Luz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ciprofloxacin Ophthalmic Ointment 0.3% and Blephaclean in people with Demodex Infestation and Demodicosis, run by Hospital de La Luz at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Demodex spp. infestation index by intervention group (time frame: One week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.