Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
Parents or guardians instilled patients' assigned study medications once on the day of surgery (Day 0) and 4 times daily (QID) beginning on the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days (dependent upon the Investigator's determination of adequate response to treatment). Patients were evaluated for safety and efficacy on the following visits: Day 0 (day of surgery), Day 1, Day 8 ± 1 day, Day 15 ± 2 days and Day 29 ± 2 days (end of study drug treatment). Additional safety visits occurred at 1 week after the last dose + 2 days and at 3 Months + 1 week. No inferential statistical analysis was planned for this study. Data was summarized using descriptive statistics.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DUREZOL | Experimental | Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
|
| PRED FORTE | Active Comparator | Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate ophthalmic emulsion, 0.05% | Drug | Topical ocular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days | Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. | Day 15 ± 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment Score of Postoperative Inflammation by Visit | A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
This reporting group includes all patients who were exposed to the study drug. One patient randomized to DUREZOL withdrew consent prior to receiving study medication.
Patients were screened and recruited from 17 study centers located within the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DUREZOL | Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| FG001 | PRED FORTE | Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are presented for all patients who were exposed to the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DUREZOL | Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days | Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits. | Posted | Number | Percentage of patients | Day 15 ± 2 days |
|
Adverse events were collected for the duration of the study. The safety population includes all patients who were exposed to the study drug.
An adverse event was considered to be any untoward medical occurrence in the health of a patient who was exposed to study medication, regardless of causal relationship with the study medication. Adverse events were obtained as solicited comments from the study patients and as observations by the study Investigator as outlined in the study protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DUREZOL | Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical observation | Investigations | MedDRA 13.0 | Systematic Assessment | Not related. Hospital admission was required for procedures involving surgery/anesthesia of certain infants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pam Kaur, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C015808 | difluprednate |
| C009935 | prednisolone acetate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prednisolone acetate ophthalmic suspension, 1.0% | Drug | Topical ocular administration |
|
|
| Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
| PRED FORTE |
Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | PRED FORTE | Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
|
|
| Secondary | Global Assessment Score of Postoperative Inflammation by Visit | A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade | Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade | Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity | Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection | Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection | Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis | Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon | Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis | Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity | Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia | Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| Secondary | Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation | Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. | Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. | Posted | Number | Percentage of patients | Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week |
|
|
|
| 8 |
| 39 |
| 16 |
| 39 |
| EG001 | PRED FORTE | Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment | 11 | 40 | 10 | 40 |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment | Not related |
|
| Intraocular pressure increased | Investigations | MedDRA 13.0 | Systematic Assessment | Related |
|
| Cataract cortical | Immune system disorders | MedDRA 13.0 | Systematic Assessment | Not related |
|
| Posterior capsule opacification | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Cataract operation (non-study eye) | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Day 1: Grade 2 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 1: Grade 4 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 8: Grade 4 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 15: Grade 4 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| Day 29: Grade 4 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| 1 Week After Last Dose: Grade 4 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Month 3: Grade 4 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 1: Grade 0 |
|
| Month 1: Grade 1 |
|
| Month 1: Grade 2 |
|
| Month 1: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|
| Day 1: Grade 2 |
|
| Day 1: Grade 3 |
|
| Day 8: Grade 0 |
|
| Day 8: Grade 1 |
|
| Day 8: Grade 2 |
|
| Day 8: Grade 3 |
|
| Day 15: Grade 0 |
|
| Day 15: Grade 1 |
|
| Day 15: Grade 2 |
|
| Day 15: Grade 3 |
|
| Day 29: Grade 0 |
|
| Day 29: Grade 1 |
|
| Day 29: Grade 2 |
|
| Day 29: Grade 3 |
|
| 1 Week after Last Dose: Grade 0 |
|
| 1 Week after Last Dose: Grade 1 |
|
| 1 Week after Last Dose: Grade 2 |
|
| 1 Week after Last Dose: Grade 3 |
|
| Month 3: Grade 0 |
|
| Month 3: Grade 1 |
|
| Month 3: Grade 2 |
|
| Month 3: Grade 3 |
|