Chalazion, Hordeolum
Conditions
Brief summary
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
Interventions
DRUGloteprednol etabonate/tobramycin opthalmic suspension
Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
DRUGvehicle
topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No
Inclusion criteria
* Child, 0 to 6 years of age, any sex and race * Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated * In good health (no current or past relevant medical history), based on the judgment of the investigator * Parent/guardian is able and willing to follow instructions and provide informed consent
Exclusion criteria
* Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication * Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication * Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study * Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study * Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration * Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study * History of ocular surgery, including laser procedures, within the past six months * Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study * Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication * History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study * Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study * Unlikely to comply with the protocol instructions for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | day 1, day 8, day 15 | Study eye - Safety Population, At all visits 1,2,3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigators Global Assessment of the Clinical Condition | Visit 3, day 8 | The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened. |
| Assessment of Ocular Signs in the Study Eye - Visit 1 | Visit 1 (day 1) | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. |
| Assessment of Ocular Signs in the Study Eye - Visit 2 | Visit 2 (day 8) | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. |
| Assessment of Ocular Signs in the Study Eye - Visit 3 | Visit 3 (day 15) | Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. |
Countries
United States
Participant flow
Recruitment details
108 subjects aged 0-6 years with lid inflammation were recruited from 15 clinic locations in the US. First subject was enrolled on 11/07/2006, last subject visit was 1/5/2009.
Pre-assignment details
108 subjects were randomized to receive loteprednol/tobramycin or its vehicle in a 2:1 ratio. Subjects will receive warm compress lid treatment 2 times daily, before administration of study medication (as applicable) for the 14-day treatment duration.
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol/Tobramycin 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days | 72 |
| Vehicle Vehicle used in the study drug administered into affected eye(s) for 14 days | 36 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawn by parent or gaurdian | 5 | 2 |
Baseline characteristics
| Characteristic | Loteprednol/Tobramycin | Vehicle | Total |
|---|---|---|---|
| Age, Customized Age 0-6 years | 72 participants | 36 participants | 108 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 10 participants | 7 participants | 17 participants |
| Race/Ethnicity, Customized Other | 7 participants | 3 participants | 10 participants |
| Race/Ethnicity, Customized White | 52 participants | 25 participants | 77 participants |
| Sex: Female, Male Female | 37 Participants | 23 Participants | 60 Participants |
| Sex: Female, Male Male | 35 Participants | 13 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 72 | 0 / 36 |
| serious Total, serious adverse events | 1 / 72 | 0 / 36 |
Outcome results
Primary
Treatment Emergent Adverse Events
Study eye - Safety Population, At all visits 1,2,3
Time frame: day 1, day 8, day 15
Population: Safety population, Study eye
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol/Tobramycin | Treatment Emergent Adverse Events | Conjunctivitis | 2 participants |
| Loteprednol/Tobramycin | Treatment Emergent Adverse Events | Meibomianitis | 1 participants |
| Loteprednol/Tobramycin | Treatment Emergent Adverse Events | Eyelid edema | 0 participants |
| Vehicle | Treatment Emergent Adverse Events | Eyelid edema | 1 participants |
| Vehicle | Treatment Emergent Adverse Events | Conjunctivitis | 0 participants |
| Vehicle | Treatment Emergent Adverse Events | Meibomianitis | 1 participants |
Secondary
Assessment of Ocular Signs in the Study Eye - Visit 1
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time frame: Visit 1 (day 1)
Population: Efficacy sample, non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 1 | Lid Edema | 1.97 Units on a scale 0-4 | Standard Deviation 0.84 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 1 | Lid Erythema | 1.98 Units on a scale 0-4 | Standard Deviation 1.1 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 1 | Palpebral Conjunctival Injection | 1.85 Units on a scale 0-4 | Standard Deviation 1.13 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 1 | Meibomian Plugging | 1.44 Units on a scale 0-4 | Standard Deviation 1.04 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 1 | Meibomian Plugging | 1.59 Units on a scale 0-4 | Standard Deviation 1.26 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 1 | Lid Edema | 2.06 Units on a scale 0-4 | Standard Deviation 0.95 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 1 | Palpebral Conjunctival Injection | 1.79 Units on a scale 0-4 | Standard Deviation 0.98 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 1 | Lid Erythema | 1.82 Units on a scale 0-4 | Standard Deviation 1.22 |
Secondary
Assessment of Ocular Signs in the Study Eye - Visit 2
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time frame: Visit 2 (day 8)
Population: Efficacy population - Study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid Edema | 1.47 Units on a scale 0-4 | Standard Deviation 0.92 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid Erythema | 1.41 Units on a scale 0-4 | Standard Deviation 1.01 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 2 | Palpebral Conjunctival Injection | 1.41 Units on a scale 0-4 | Standard Deviation 1.01 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 2 | Meibomian Plugging | 1.06 Units on a scale 0-4 | Standard Deviation 1.02 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 2 | Meibomian Plugging | 1.00 Units on a scale 0-4 | Standard Deviation 1.11 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid Edema | 1.38 Units on a scale 0-4 | Standard Deviation 0.94 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 2 | Palpebral Conjunctival Injection | 1.16 Units on a scale 0-4 | Standard Deviation 0.92 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 2 | Lid Erythema | 1.47 Units on a scale 0-4 | Standard Deviation 1.08 |
Secondary
Assessment of Ocular Signs in the Study Eye - Visit 3
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time frame: Visit 3 (day 15)
Population: Efficacy sample - Study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid Edema | 1.03 Units on a scale 0-4 | Standard Deviation 0.9 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid Erythema | 1.00 Units on a scale 0-4 | Standard Deviation 0.88 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 3 | Palpebral Conjunctival Injection | 1.11 Units on a scale 0-4 | Standard Deviation 0.95 |
| Loteprednol/Tobramycin | Assessment of Ocular Signs in the Study Eye - Visit 3 | Meibomian Plugging | 0.86 Units on a scale 0-4 | Standard Deviation 1.12 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 3 | Meibomian Plugging | 1.16 Units on a scale 0-4 | Standard Deviation 1.22 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid Edema | 1.41 Units on a scale 0-4 | Standard Deviation 1.1 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 3 | Palpebral Conjunctival Injection | 1.09 Units on a scale 0-4 | Standard Deviation 1.09 |
| Vehicle | Assessment of Ocular Signs in the Study Eye - Visit 3 | Lid Erythema | 1.50 Units on a scale 0-4 | Standard Deviation 1.14 |
Secondary
Investigators Global Assessment of the Clinical Condition
The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.
Time frame: Visit 3, day 8
Population: Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loteprednol/Tobramycin | Investigators Global Assessment of the Clinical Condition | Improved | 36 Participants |
| Loteprednol/Tobramycin | Investigators Global Assessment of the Clinical Condition | Unchanged | 25 Participants |
| Loteprednol/Tobramycin | Investigators Global Assessment of the Clinical Condition | Worse | 2 Participants |
| Vehicle | Investigators Global Assessment of the Clinical Condition | Improved | 17 Participants |
| Vehicle | Investigators Global Assessment of the Clinical Condition | Unchanged | 13 Participants |
| Vehicle | Investigators Global Assessment of the Clinical Condition | Worse | 2 Participants |