Trial · NCT01060072
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
NCT01060072, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2012-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery. Trials, record NCT01060072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01060072
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
- NCT number
- NCT01060072
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 407 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Inflammation, Pain
- Interventions
- Loteprednol etabonate, Vehicle of Loteprednol Etabonate
- First posted
- 2010-02-02
- Last updated
- 2012-01-13
- Results first posted
- 2012-01-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Resolution of Anterior Chamber Cells. | Visit 5 (Postoperative day 8) | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells |
| Primary | Grade 0 Pain | Visit 5 (Postoperative day 8) | Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain |
| Secondary | Resolution of Anterior Chamber Cells | Visit 4-7 (postoperative day 3-18) | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells |
| Secondary | Grade 0 Pain | Visits 4-7 (Postoperative days 3-18) | Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain |
| Secondary | Resolution of Anterior Chamber Flare | Visit 4-7 (postoperative day 3-18) | Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Resolution of Anterior Chamber Cells. | Visit 5 (Postoperative day 8) | Intention to treat (ITT) population | participants | NUMBER |
| PRIMARY | Grade 0 Pain | Visit 5 (Postoperative day 8) | Intention to treat (ITT) population | participants | NUMBER |
| SECONDARY | Resolution of Anterior Chamber Cells | Visit 4-7 (postoperative day 3-18) | Intention to treat population (ITT) | participants | NUMBER |
| SECONDARY | Grade 0 Pain | Visits 4-7 (Postoperative days 3-18) | Intention to treat population (ITT) | participants | NUMBER |
| SECONDARY | Resolution of Anterior Chamber Flare | Visit 4-7 (postoperative day 3-18) | Intention to treat population (ITT) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Resolution of Anterior Chamber Cells. | Loteprednol Etabonate | 64 | participants | ||
| Resolution of Anterior Chamber Cells. | Vehicle | 28 | participants | ||
| Grade 0 Pain | Loteprednol Etabonate | 156 | participants | ||
| Grade 0 Pain | Vehicle | 92 | participants | ||
| Resolution of Anterior Chamber Cells | Loteprednol Etabonate | Visit 4 (Postoperative Day 3) | 8 | participants | |
| Resolution of Anterior Chamber Cells | Vehicle | Visit 4 (Postoperative Day 3) | 7 | participants | |
| Resolution of Anterior Chamber Cells | Loteprednol Etabonate | Visit 5 (Postoperative Day 8) | 64 | participants | |
| Resolution of Anterior Chamber Cells | Vehicle | Visit 5 (Postoperative Day 8) | 28 | participants | |
| Resolution of Anterior Chamber Cells | Loteprednol Etabonate | Visit 6 (Postoperative Day 15) | 116 | participants | |
| Resolution of Anterior Chamber Cells | Vehicle | Visit 6 (Postoperative Day 15) | 61 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 | 206 | |
| Overall Study | STARTED | Vehicle | 201 | |
| Overall Study | COMPLETED | Loteprednol Etabonate | 204 | |
| Overall Study | COMPLETED | Vehicle | 196 | |
| Overall Study | NOT COMPLETED | Loteprednol Etabonate | 2 | |
| Overall Study | NOT COMPLETED | Vehicle | 5 |
Source ClinicalTrials.gov
Adverse events14
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 | 7 | 206 | 7 |
| other | Anterior Chamber Inflammation | Eye disorders | Vehicle | 14 | 201 | 14 |
| other | Eye Pain | Eye disorders | Loteprednol Etabonate | 3 | 206 | 3 |
| other | Eye Pain | Eye disorders | Vehicle | 10 | 201 | 10 |
| serious | Diverticulitis | Gastrointestinal disorders | Loteprednol Etabonate | 1 | 206 | 1 |
| serious | Diverticulitis | Gastrointestinal disorders | Vehicle | 0 | 201 | 0 |
| serious | Cholecystitis | Gastrointestinal disorders | Loteprednol Etabonate | 1 | 206 | 1 |
| serious | Cholecystitis | Gastrointestinal disorders | Vehicle | 0 | 201 | 0 |
| serious | Myocardial infarction | Cardiac disorders | Loteprednol Etabonate | 1 | 206 | 1 |
| serious | Myocardial infarction | Cardiac disorders | Vehicle | 0 | 201 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 10 | 206 |
| Total, other adverse events | Vehicle | 24 | 201 |
| Total, serious adverse events | Loteprednol Etabonate | 3 | 206 |
| Total, serious adverse events | Vehicle | 1 | 201 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24136301 | DERIVED |
Source PubMed
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: Grade 0 Pain | Trial comparisons |
| Loteprednol Etabonate vs Vehicle: Resolution of Anterior Chamber Cells. | 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/NCT01060072
GET https://conductscience.org/api/trials/v1/NCT01060072/results?page=2