Trial · NCT00699153
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
NCT00699153, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2010-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery. Trials, record NCT00699153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00699153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
- NCT number
- NCT00699153
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 400 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Ocular Inflammation
- Interventions
- Loteprednol Etabonate, Vehicle of Ophthalmic Loteprednol Etabonate
- First posted
- 2008-06-17
- Last updated
- 2015-03-24
- Results first posted
- 2010-09-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | Postoperative day 8 (Visit 5) | Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no. | participants | NUMBER |
| PRIMARY | Participants With Grade 0 (no) Pain | Postoperative day 8 (Visit 5) | Intent to treat population | participants | NUMBER |
| SECONDARY | Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | At each visit: Visit 4-7, postoperative days 3-18 | Intent to treat population | participants | NUMBER |
| SECONDARY | 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) | Intent to treat population. | Composite scores | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | Loteprednol Etabonate | 64 | participants | ||
| Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | Vehicle | 23 | participants | ||
| Participants With Grade 0 (no) Pain | Loteprednol Etabonate | 149 | participants | ||
| Participants With Grade 0 (no) Pain | Vehicle | 83 | participants | ||
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Loteprednol Etabonate | Visit 4, postoperative day 3 | 10 | participants | |
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Vehicle | Visit 4, postoperative day 3 | 9 | participants | |
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Loteprednol Etabonate | Visit 5, postoperative day 8 | 64 | participants | |
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Vehicle | Visit 5, postoperative day 8 | 23 | participants | |
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Loteprednol Etabonate | Visit 6, posoperative day 15 | 107 | participants | |
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. | Vehicle | Visit 6, posoperative day 15 | 42 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Loteprednol Etabonate | 203 | |
| Overall Study | STARTED | Vehicle | 202 | |
| Overall Study | COMPLETED | Loteprednol Etabonate | 200 | |
| Overall Study | COMPLETED | Vehicle | 200 | |
| Overall Study | NOT COMPLETED | Loteprednol Etabonate | 3 | |
| Overall Study | NOT COMPLETED | Vehicle | 2 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anterior chamber inflammation | Eye disorders | Loteprednol Etabonate | 49 | 204 | 119 |
| other | Anterior chamber inflammation | Eye disorders | Vehicle | 94 | 201 | 241 |
| other | Eye Pain | Eye disorders | Loteprednol Etabonate | 7 | 204 | 119 |
| other | Eye Pain | Eye disorders | Vehicle | 17 | 201 | 241 |
| other | Corneal Edema | Eye disorders | Loteprednol Etabonate | 10 | 204 | 119 |
| other | Corneal Edema | Eye disorders | Vehicle | 12 | 201 | 241 |
| other | Conjunctival Hyperemia | Eye disorders | Loteprednol Etabonate | 6 | 204 | 119 |
| other | Conjunctival Hyperemia | Eye disorders | Vehicle | 15 | 201 | 241 |
| other | Ciliary Hyperemia | Eye disorders | Loteprednol Etabonate | 5 | 204 | 119 |
| other | Ciliary Hyperemia | Eye disorders | Vehicle | 13 | 201 | 241 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Loteprednol Etabonate | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | Loteprednol Etabonate | 81 | 204 |
| Total, other adverse events | Vehicle | 151 | 201 |
| Total, serious adverse events | Loteprednol Etabonate | 2 | 204 |
| Total, serious adverse events | Vehicle | 4 | 201 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Loteprednol Etabonate vs Vehicle: Participants With Grade 0 (no) Pain | Trial comparisons |
| Loteprednol Etabonate vs Vehicle: Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 | Trial comparisons |
| Loteprednol Etabonate vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00699153
GET https://conductscience.org/api/trials/v1/NCT00699153/events?page=2