Sebaceous Gland DiseasesNCT02455895
Efficacy of iLid Cleanser (Avenova) Versus Vehicle on Ocular Skin Flora
A study testing iLid Cleanser in people with Sebaceous Gland Diseases and Blepharitis, run by NovaBay Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its Vehicle, on the ocular skin flora. In the pre-randomization phase, subjects will receive a single application of open-label NovaBay iLid Cleanser. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Sebaceous Gland Diseases, Blepharitis
- What is being tested?
- iLid Cleanser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to May 2016
- Phase
- Interventional
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, of any race, at least 6 years of age.
- Must be eligible for a recommendation to use eye lid cleansing/scrubs for:
- Signs of acute or chronic blepharitis, such as eye lid debris (sleeves, collorates, flakes, crusting) requiring eye lid cleansing/scrubs, and/or
- Signs consistent with mild, moderate, or severe meibomian gland disease (MGD) such as dilated and blocked glands with inspissated secretions sluggish or stagnant upon expression.
- Must be able to read, understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee. If subject is less than 18 years of age, the informed consent must be signed and dated by subject's legally authorized representative (parent or guardian). Assent to participate should also be obtained from subjects under 18 years of age if required by local regulation.
- Must agree to comply with the visit schedule and other requirements of the study. The parent or guardian must agree to ensure compliance of subjects less than 18 years of age.
- Must agree to remove contact lenses, if applicable, for 15 minutes before and after application of the study Investigational Product.
- Must agree for the duration of the study to refrain from use of makeup/cosmetic products used around the eye(s) such as eye liner, mascara, and/or shadow, foundation or powder. Use of such products is allowed if the eyelid skin area is avoided.
Who cannot join
- Presence of signs and symptoms of bacterial or allergic conjunctivitis or allergic dermatitis at the Day 1 Visit.
- Suspected fungal, viral, Chlamydia or Acanthamoeba infection based on clinical diagnosis.
- Visual acuity not correctable to 1.0 LogMAR or better (equivalent to Snellen 20/200) in either eye using either a Snellen or ETDRS chart.
- Use of any topical ocular medications including tear substitutes during study participation.
- Use of any preserved or non-preserved glaucoma medications during the 14 days prior to Visit 1 and anticipated use during study participation.
- Presence of nasolacrimal duct obstruction.
Show all 16Show fewer
- Presence of a punctal plug in either eye.
- Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Presence of active inflammation and/or active structural change in the cornea, iris or anterior chamber at the Day 1 visit.
- Use of any topical ocular or oral antimicrobial agent within the 3 days prior to Day 1 visit.
- Use of topical ocular corticosteroids or non-steroidal topical ocular anti-inflammatories (NSAIDs), within 3 days prior to study entry and during the trial.
- Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%) in either eye during the trial.
- Any current immunosuppressive disorder (e.g., HIV positive), or use of immunosuppressive therapy (including chemotherapy).
- Participation in any other investigational clinical study within 30 days prior to study enrollment.
- Any subject who is on staff at the investigational site or is a family member of staff personnel.
- Additionally, the Investigator or Medical Monitor may declare any subject ineligible for a sound medical reason.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Ophthalmic Research Consultants of Arizona
Phoenix, Arizona, 85032
Andrea Sarich, 602-549-2020, sarich.andrea@gmail.com
Arthur Epstein, OD
- Recruiting
Turner Eye Institute
San Leandro, California, 94577
Erika Chang, 800-339-2733, echang@turnereye.com
Chirag Patel, MD
- Recruiting
James D. Branch, MD
Winston-Salem, North Carolina, 27101
Elaine Acosta, 336-721-4711, emaeye@hotmail.com
James Branch, MD
About this study
Official title: A Multicenter Randomized, Double-Masked Study Comparing the Efficacy of Novabay iLid Cleanser Versus Vehicle on Ocular Skin Flora
This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its Vehicle, on the ocular skin flora.
In the pre-randomization phase, subjects will receive a single application of open-label NovaBay iLid Cleanser.
In the randomization phase of Stages 1 and 2, subjects will self-treat with masked Investigational Product twice daily for ten (10) days.
Read the detailed description
This is an adaptive design, randomized, double-masked, vehicle-controlled, multicenter, parallel group study with two treatment arms: NovaBay iLid Cleanser ("Cleanser") and Cleanser Vehicle ("Vehicle").
The study will be conducted in two Stages, each preceded by a pre-randomization phase. Randomization of Cleanser:Vehicle will be 1:1 and 2:1 in Stages 1 and 2 respectively.
In the pre-randomization phase for Stages 1 and 2, subjects who meet all inclusion and no exclusion criteria will be evaluated by clinical examination at a single visit prior to having ocular skin specimens taken before and after treatment with open-label Cleanser.
In the randomization phase for both Stages 1 and 2, subjects who meet all inclusion and no exclusion criteria will be randomized and evaluated at three visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 11 (+2) End of Treatment (EOT)
- Visit 3: Day 18 (±2) Post Treatment Evaluation/Exit Subjects will have ocular skin specimens taken at Visit 1, Day 1. The specimens will be collected before and 20 minutes after the first application of the study Investigational Product performed by study personnel.
- Conditions
- Sebaceous Gland Diseases, Blepharitis
- Being tested
- iLid Cleanser
- Keywords
- Blepharitis
- Medical subject headings
- Sebaceous Gland Diseases, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLid CleanserDevice
Also called Avenova
Application of iLid Cleanser to reduce bacterial load on the lid and lash margins
| Study group | Role | What they receive |
|---|---|---|
| iLid Cleanser (Avenova) | Active comparator | iLid Cleanser - applied 2 times per day for 10 days Receives: Device: iLid Cleanser |
| iLid Cleanser Vehicle | Placebo comparator | iLid Cleanser Vehicle - applied 2 times per day for 10 days Receives: Device: iLid Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological efficacy
Quantitative assessment of numbers of recoverable bacteria before versus after application of test article
Measured: 20 minutes after application of test article
Secondary outcomes (1)
Ocular Signs
lid erythema, lid swelling, lid crusting and debris on lashes, bulbar and palpebral conjunctival injection, and meibomian gland secretions (after expression)
Measured: Assessed on Visit 1(Day 1), Visit 2 (Day 11) and Visit 3 (Day 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sebaceous Gland DiseasesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David W. Stroman, Ph.D., Study director, NovaBay Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455895
- Sponsor's protocol ID
- CM-01-14
- Status last verified
- May 2015
- First submitted
- 26 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Double-Masked Study Comparing the Efficacy of Novabay iLid Cleanser Versus Vehicle on Ocular Skin Flora
- ClinicalTrials.gov ID
- NCT02455895
- Acronym / sponsor ID
- CM-01-14
- Conditions
- Sebaceous Gland Diseases, Blepharitis
- Keywords
- Blepharitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 28 May 2015 (estimated)
- 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.
This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its Vehicle, on the ocular skin flora.
In the pre-randomization phase, subjects will receive a single application of open-label NovaBay iLid Cleanser.
In the randomization phase of Stages 1 and 2, subjects will self-treat with masked Investigational Product twice daily for ten (10) days.
Detailed description
This is an adaptive design, randomized, double-masked, vehicle-controlled, multicenter, parallel group study with two treatment arms: NovaBay iLid Cleanser ("Cleanser") and Cleanser Vehicle ("Vehicle").
The study will be conducted in two Stages, each preceded by a pre-randomization phase. Randomization of Cleanser:Vehicle will be 1:1 and 2:1 in Stages 1 and 2 respectively.
In the pre-randomization phase for Stages 1 and 2, subjects who meet all inclusion and no exclusion criteria will be evaluated by clinical examination at a single visit prior to having ocular skin specimens taken before and after treatment with open-label Cleanser.
In the randomization phase for both Stages 1 and 2, subjects who meet all inclusion and no exclusion criteria will be randomized and evaluated at three visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 11 (+2) End of Treatment (EOT)
- Visit 3: Day 18 (±2) Post Treatment Evaluation/Exit Subjects will have ocular skin specimens taken at Visit 1, Day 1. The specimens will be collected before and 20 minutes after the first application of the study Investigational Product performed by study personnel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iLid Cleanser (Avenova) | Active comparator | Device: iLid CleanseriLid Cleanser - applied 2 times per day for 10 days |
| iLid Cleanser Vehicle | Placebo comparator | Device: iLid CleanseriLid Cleanser Vehicle - applied 2 times per day for 10 days |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, of any race, at least 6 years of age.
- Must be eligible for a recommendation to use eye lid cleansing/scrubs for:
- Must be able to read, understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee. If subject is less than 18 years of age, the informed consent must be signed and dated by subject's legally authorized representative (parent or guardian). Assent to participate should also be obtained from subjects under 18 years of age if required by local regulation.
- Must agree to comply with the visit schedule and other requirements of the study. The parent or guardian must agree to ensure compliance of subjects less than 18 years of age.
- Must agree to remove contact lenses, if applicable, for 15 minutes before and after application of the study Investigational Product.
Key exclusion criteria (16 listed)
- Presence of signs and symptoms of bacterial or allergic conjunctivitis or allergic dermatitis at the Day 1 Visit.
- Suspected fungal, viral, Chlamydia or Acanthamoeba infection based on clinical diagnosis.
- Visual acuity not correctable to 1.0 LogMAR or better (equivalent to Snellen 20/200) in either eye using either a Snellen or ETDRS chart.
- Use of any topical ocular medications including tear substitutes during study participation.
- Use of any preserved or non-preserved glaucoma medications during the 14 days prior to Visit 1 and anticipated use during study participation.
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 |
|---|---|---|
| iLid CleanserAlso: AvenovaApplication of iLid Cleanser to reduce bacterial load on the lid and lash margins | Device | iLid Cleanser (Avenova), iLid Cleanser Vehicle |
Primary outcome
Microbiological efficacy
Time frame: 20 minutes after application of test article
Quantitative assessment of numbers of recoverable bacteria before versus after application of test article
1 secondary outcome
Ocular Signs
Time frame: Assessed on Visit 1(Day 1), Visit 2 (Day 11) and Visit 3 (Day 18)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Related trials for Sebaceous Gland Diseases
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
David W. Stroman, Ph.D. study director
NovaBay Pharmaceuticals, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLid Cleanser in people with Sebaceous Gland Diseases and Blepharitis, run by NovaBay Pharmaceuticals, Inc. at 3 sites in United States.
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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Stroman, Ph.D. (510-899-8813, dstroman@novabay.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological efficacy (time frame: 20 minutes after application of test article). 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 28 May 2015.