Trial · NCT00645671
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
NCT00645671, 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 Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery. Trials, record NCT00645671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00645671
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
- NCT number
- NCT00645671
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 400 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Ocular Inflammation
- Interventions
- 0.5% Loteprednol Etabonate Ophthalmic Ointment, Vehicle of Loteprednol Etabonate Ophthalmic Ointment
- First posted
- 2008-03-28
- 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 | Subjects 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 | Grade 0 for 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 | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | At each follow-up visit through day18 (Visit 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. |
| Secondary | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Baseline and each follow-up visit through day18 (Visit 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 | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Postoperative Day 8 (Visit 5) | Intent to treat population | participants | NUMBER |
| SECONDARY | Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | At each follow-up visit through day18 (Visit 7) | Intent to treat population | participants | NUMBER |
| SECONDARY | Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | Baseline and each follow-up visit through day18 (Visit 7) | Intent to treat population | Composit scores | MEAN |
| PRIMARY | Grade 0 for Pain | Postoperative Day 8 (Visit 5) | Intent to treat population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Loteprednol Etabonate | Yes | 48 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Vehicle | Yes | 27 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Loteprednol Etabonate | No | 153 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | Vehicle | No | 172 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Loteprednol Etabonate | Visit 4 (postoperative day 3) | 10 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Vehicle | Visit 4 (postoperative day 3) | 9 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Loteprednol Etabonate | Visit 5 (postoperative day 8) | 48 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Vehicle | Visit 5 (postoperative day 8) | 27 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Loteprednol Etabonate | Visit 6 (postoperative day 15) | 84 | participants | |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | Vehicle | Visit 6 (postoperative day 15) | 30 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 201 | |
| Overall Study | STARTED | Vehicle | 199 | |
| Overall Study | COMPLETED | Loteprednol Etabonate | 200 | |
| Overall Study | COMPLETED | Vehicle | 193 | |
| Overall Study | NOT COMPLETED | Loteprednol Etabonate | 1 | |
| Overall Study | NOT COMPLETED | Vehicle | 6 |
Source ClinicalTrials.gov
Adverse events30
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 cell | Eye disorders | Loteprednol Etabonate | 5 | 201 | 15 |
| other | Anterior chamber cell | Eye disorders | Vehicle | 10 | 199 | 15 |
| other | Anterior chamber inflammation | Eye disorders | Loteprednol Etabonate | 61 | 201 | 167 |
| other | Anterior chamber inflammation | Eye disorders | Vehicle | 106 | 199 | 167 |
| other | Ciliary hyperemia | Eye disorders | Loteprednol Etabonate | 5 | 201 | 15 |
| other | Ciliary hyperemia | Eye disorders | Vehicle | 10 | 199 | 15 |
| other | Conjunctival hyperemia | Eye disorders | Loteprednol Etabonate | 10 | 201 | 25 |
| other | Conjunctival hyperemia | Eye disorders | Vehicle | 15 | 199 | 25 |
| other | Corneal edema | Eye disorders | Loteprednol Etabonate | 8 | 201 | 19 |
| other | Corneal edema | Eye disorders | Vehicle | 11 | 199 | 19 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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 | 110 | 201 |
| Total, other adverse events | Vehicle | 161 | 199 |
| Total, serious adverse events | Loteprednol Etabonate | 3 | 201 |
| Total, serious adverse events | Vehicle | 2 | 199 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Loteprednol Etabonate vs Vehicle: serious adverse events |
Source 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/NCT00645671
GET https://conductscience.org/api/trials/v1/NCT00645671/results?page=2