Cataract
Conditions
Keywords
Pediatric cataract
Brief summary
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
Detailed description
The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
Interventions
1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
DRUGPrednisolones acetate
1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 11 Years
Healthy volunteers
No
Inclusion criteria
* Subject is a candidate for routine, uncomplicated surgery for childhood cataract
Exclusion criteria
* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up. * Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically. * Subjects with a history of steroid-induced IOP elevation in either eye. * Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Inflammation | Postoperative Day 29 | Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D \[g20 Diopter\] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Cells & Flare | Over all visits 42 days | Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect 1. = Mild Tyndall effect barely discernible 2. = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly 3. = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly 4. = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate Loteprednol etabonate 0.5%
Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. | 53 |
| Prednisolones Acetate Prednisolone acetate 1.0%
Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. | 52 |
| Total | 105 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate | Total | Prednisolones Acetate |
|---|---|---|---|
| Age, Continuous | 3.7 years STANDARD_DEVIATION 3.22 | 4 years STANDARD_DEVIATION 3.305 | 4.3 years STANDARD_DEVIATION 3.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 44 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 61 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 18 Participants | 36 Participants | 18 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 49 Participants | 23 Participants |
| Region of Enrollment United States | 53 participants | 105 participants | 52 participants |
| Sex: Female, Male Female | 22 Participants | 48 Participants | 26 Participants |
| Sex: Female, Male Male | 31 Participants | 57 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 53 |
| other Total, other adverse events | 34 / 54 | 23 / 53 |
| serious Total, serious adverse events | 3 / 54 | 0 / 53 |
Outcome results
Primary
Anterior Chamber Inflammation
Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D \[g20 Diopter\] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished
Time frame: Postoperative Day 29
Population: Proportion of subjects with anterior chamber inflammation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Loteprednol Etabonate | Anterior Chamber Inflammation | .913 grade of anterior chamber cells |
| Prednisolones Acetate | Anterior Chamber Inflammation | .783 grade of anterior chamber cells |
Secondary
Anterior Chamber Cells & Flare
Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect 1. = Mild Tyndall effect barely discernible 2. = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly 3. = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly 4. = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance
Time frame: Over all visits 42 days
Population: Proportion of subjects with anterior chamber flare.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Loteprednol Etabonate | Anterior Chamber Cells & Flare | .192 Grade of anterior chamber flare |
| Prednisolones Acetate | Anterior Chamber Cells & Flare | .341 Grade of anterior chamber flare |