Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Study Details
Study Description
Brief Summary
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Loteprednol Etabonate Loteprednol Etabonate 0.5% |
Drug: Loteprednol Etabonate
Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
|
| Placebo Comparator: Vehicle Vehicle of Ophthalmic Loteprednol Etabonate |
Drug: Vehicle of Ophthalmic Loteprednol Etabonate
Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.
|
Outcome Measures
Primary Outcome Measures
- Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 [Postoperative day 8 (Visit 5)]
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
- Participants With Grade 0 (no) Pain [Postoperative day 8 (Visit 5)]
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
Secondary Outcome Measures
- Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. [At each visit: Visit 4-7, postoperative days 3-18]
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
- Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare [Postoperative Day 3-18 (Each follow-up Visit 4-7)]
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects at least 18 years of age
-
Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
-
Subjects who are candidate for routine, uncomplicated cataract surgery.
-
Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
-
Subjects must be willing and able to comply with all treatment and follow- up procedures.
Exclusion Criteria:
-
Subjects who have known hypersensitivity or contraindication to the study drug or its components.
-
Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
-
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 elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
-
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
-
Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
-
Women who are pregnant or breast feeding.
-
Subjects who have participated in an investigational drug or device study within the last 30 days.
-
Subjects previously randomized in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cornerstone Eye Wear | High Point | North Carolina | United States | 27262 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Laura Trusso, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 526
Study Results
Participant Flow
| Recruitment Details | This study was conducted at 16 sites in the US. The first participant was enrolled June 20, 2008 and the last participant visit was May 1, 2009. |
|---|---|
| Pre-assignment Detail | 405 participants, who were candidates for routine, uncomplicated cataract surgery were enrolled in the study. |
| Arm/Group Title | Loteprednol Etabonate | Vehicle |
|---|---|---|
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate |
| Period Title: Overall Study | ||
| STARTED | 203 | 202 |
| COMPLETED | 200 | 200 |
| NOT COMPLETED | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | Loteprednol Etabonate | Vehicle | Total |
|---|---|---|---|
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate | Total of all reporting groups |
| Overall Participants | 203 | 202 | 405 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
68.3
(9.13)
|
69.2
(9.36)
|
68.8
(9.24)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
115
56.7%
|
115
56.9%
|
230
56.8%
|
| Male |
88
43.3%
|
87
43.1%
|
175
43.2%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| White |
182
89.7%
|
178
88.1%
|
360
88.9%
|
| Black/African American |
13
6.4%
|
16
7.9%
|
29
7.2%
|
| American Indian/Alaskan Native |
2
1%
|
0
0%
|
2
0.5%
|
| Asian |
5
2.5%
|
6
3%
|
11
2.7%
|
| Native Hawiian/Pacific Islander |
0
0%
|
1
0.5%
|
1
0.2%
|
| Other |
1
0.5%
|
1
0.5%
|
2
0.5%
|
Outcome Measures
| Title | Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 |
|---|---|
| Description | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
| Time Frame | Postoperative day 8 (Visit 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no. |
| Arm/Group Title | Loteprednol Etabonate | Vehicle |
|---|---|---|
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate |
| Measure Participants | 203 | 202 |
| Number [participants] |
64
31.5%
|
23
11.4%
|
| Title | Participants With Grade 0 (no) Pain |
|---|---|
| Description | Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe |
| Time Frame | Postoperative day 8 (Visit 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population |
| Arm/Group Title | Loteprednol Etabonate | Vehicle |
|---|---|---|
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate |
| Measure Participants | 203 | 202 |
| Number [participants] |
149
73.4%
|
83
41.1%
|
| Title | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. |
|---|---|
| Description | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
| Time Frame | At each visit: Visit 4-7, postoperative days 3-18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population |
| Arm/Group Title | Loteprednol Etabonate | Vehicle |
|---|---|---|
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate |
| Measure Participants | 203 | 202 |
| Visit 4, postoperative day 3 |
10
4.9%
|
9
4.5%
|
| Visit 5, postoperative day 8 |
64
31.5%
|
23
11.4%
|
| Visit 6, posoperative day 15 |
107
52.7%
|
42
20.8%
|
| Visit 7, postoperative day 18 |
100
49.3%
|
46
22.8%
|
| Title | Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare |
|---|---|
| Description | A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. |
| Time Frame | Postoperative Day 3-18 (Each follow-up Visit 4-7) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population. |
| Arm/Group Title | Loteprednol Etabonate | Vehicle |
|---|---|---|
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate |
| Measure Participants | 203 | 202 |
| Visit 4, postoperative day 3 |
-1.2
(1.20)
|
-0.6
(1.48)
|
| Visit 5, postoperative day 8 |
-2.2
(1.51)
|
-0.8
(1.81)
|
| Visit 6, postoperative day 15 |
-2.7
(1.58)
|
-1.1
(1.94)
|
| Visit 7, postoperative day 18 |
-2.6
(1.59)
|
-1.1
(2.01)
|
Adverse Events
| Time Frame | Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Ocular treatment related ocular AE's in >/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle. | |||
| Arm/Group Title | Loteprednol Etabonate | Vehicle | ||
| Arm/Group Description | Loteprednol Etabonate Ophthalmic Ointment 0.5% | Vehicle of Ophthalmic Loteprednol Etabonate | ||
All Cause Mortality |
||||
| Loteprednol Etabonate | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Loteprednol Etabonate | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/204 (1%) | 4/201 (2%) | ||
| Cardiac disorders | ||||
| Blocked arteries | 2/204 (1%) | 2 | 2/201 (1%) | 2 |
| Endocrine disorders | ||||
| Diabetic foot ulcer | 1/204 (0.5%) | 1 | 1/201 (0.5%) | 1 |
| Pituitary tumor | 1/204 (0.5%) | 1 | 1/201 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Fall/Hip fracture | 2/204 (1%) | 2 | 2/201 (1%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| Loteprednol Etabonate | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 81/204 (39.7%) | 151/201 (75.1%) | ||
| Eye disorders | ||||
| Anterior chamber inflammation | 49/204 (24%) | 119 | 94/201 (46.8%) | 241 |
| Eye Pain | 7/204 (3.4%) | 119 | 17/201 (8.5%) | 241 |
| Corneal Edema | 10/204 (4.9%) | 119 | 12/201 (6%) | 241 |
| Conjunctival Hyperemia | 6/204 (2.9%) | 119 | 15/201 (7.5%) | 241 |
| Ciliary Hyperemia | 5/204 (2.5%) | 119 | 13/201 (6.5%) | 241 |
| Photophobia | 5/204 (2.5%) | 119 | 12/201 (6%) | 241 |
| Iritis | 4/204 (2%) | 119 | 12/201 (6%) | 241 |
| Uveitis | 4/204 (2%) | 119 | 10/201 (5%) | 241 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with, the Sponsor and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee for comment.
Results Point of Contact
| Name/Title | Laura Trusso, MS. |
|---|---|
| Organization | Bausch & Lomb, Inc. |
| Phone | (585) 338-5561 |
| laura.trusso@bausch.com |
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