Trial · NCT02786901
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
NCT02786901, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2020-04-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery. Trials, record NCT02786901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02786901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
- NCT number
- NCT02786901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Cataract, Pain, Ocular Inflammation
- Interventions
- Loteprednol Etabonate Ophthalmic Gel dosed TID, Loteprednol Etabonate Ophthalmic Gel dosed BID, Vehicle Gel
- First posted
- 2016-06-01
- Last updated
- 2021-01-08
- Results first posted
- 2020-04-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) | 8 days | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. |
| Primary | Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) | 8 days | Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0. |
| Secondary | Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. | 14 days | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. |
| Secondary | Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit | 14 days | Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0. |
| Secondary | Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit | 14 days | Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution. |
| Secondary | Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit | 14 days | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution. |
| Secondary | Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit | 14 days | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). The combined endpoint was defined as the sum of the scores for AC cells and AC flare. Summed Anterior Chamber (AC) Cell and Flare Scores could range from 0 to 8. |
| Secondary | Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8) | 8 days | A participant was considered a treatment failure at Visit 5 if they started any rescue medication prior to, or on the day of, Visit 5. If a subject did not have a Visit 5, due either to early discontinuation or to a missed visit, then treatment failure at Visit 5 was defined as starting rescue medication prior to, or on, Postoperative Day 8. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) | 8 days | Missing values and post rescue values imputed as failures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) | 8 days | Missing values and post rescue values imputed as failures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. | 14 days | Missing values and post rescue values imputed as failures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit | 14 days | Missing values and post rescue values imputed as failures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit | 14 days | Missing values and post rescue values imputed as failures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit | 14 days | Missing values and post rescue values imputed as failures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit | 14 days | Missing values and post-rescue values imputed using last observation carried forward. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8) | 8 days | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) | Vehicle BID and TID | 40 | Participants | ||
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) | LE Gel BID | 52 | Participants | ||
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) | LE Gel TID | 61 | Participants | ||
| Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) | Vehicle BID and TID | 99 | Participants | ||
| Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) | LE Gel BID | 151 | Participants | ||
| Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) | LE Gel TID | 151 | Participants | ||
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. | Vehicle BID and TID | 67 | Participants | ||
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. | LE Gel BID | 82 | Participants | ||
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. | LE Gel TID | 94 | Participants | ||
| Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit | Vehicle BID and TID | 122 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle BID and TID | 199 | |
| Overall Study | STARTED | LE Gel BID | 201 | |
| Overall Study | STARTED | LE Gel TID | 200 | |
| Overall Study | COMPLETED | Vehicle BID and TID | 122 | |
| Overall Study | COMPLETED | LE Gel BID | 145 | |
| Overall Study | COMPLETED | LE Gel TID | 159 | |
| Overall Study | NOT COMPLETED | Vehicle BID and TID | 77 | |
| Overall Study | NOT COMPLETED | LE Gel BID | 56 | |
| Overall Study | NOT COMPLETED | LE Gel TID | 41 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Hypokalemia | Metabolism and nutrition disorders | Vehicle BID and TID | 1 | 198 | 1 |
| serious | Hypokalemia | Metabolism and nutrition disorders | LE Gel BID | 0 | 202 | 0 |
| serious | Hypokalemia | Metabolism and nutrition disorders | LE Gel TID | 0 | 199 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle BID and TID | 0 | 198 |
| Total, all-cause mortality | LE Gel BID | 0 | 202 |
| Total, all-cause mortality | LE Gel TID | 0 | 199 |
| Total, other adverse events | Vehicle BID and TID | 0 | 198 |
| Total, other adverse events | LE Gel BID | 0 | 202 |
| Total, other adverse events | LE Gel TID | 0 | 199 |
| Total, serious adverse events | Vehicle BID and TID | 1 | 198 |
| Total, serious adverse events | LE Gel BID | 0 | 202 |
| Total, serious adverse events | LE Gel TID | 0 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02786901
GET https://conductscience.org/api/trials/v1/NCT02786901/results?page=2