Trial · NCT02208297
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
NCT02208297, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2020-09-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery. Trials, record NCT02208297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02208297
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
- NCT number
- NCT02208297
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 326 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Inflammation, Pain, Cataract
- Interventions
- Loteprednol Etabonate Gel (BID), Vehicle Gel (BID)
- First posted
- 2014-08-05
- Last updated
- 2020-09-25
- Results first posted
- 2020-09-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | 8 days | 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. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. |
| Primary | Percentage of Participants With Grade 0 Pain in the Study Eye. | 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 the 6-point scale, with 0=None and 5=Severe. |
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | 18 days | 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. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. |
| Secondary | Percentage of Participants With Grade 0 Pain in the Study Eye by Visit. | 18 days | 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. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. |
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit. | 18 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 the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0. |
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit. | 18 days | 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. Lower score indicated better outcome. 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 the 5-point scale, with 0=None (best) and 4=Very Severe (worst). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | 8 days | The analysis population included all randomized participants, with missing values imputed as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Grade 0 Pain in the Study Eye. | 8 days | The analysis population included all randomized participants, with missing values imputed as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | 18 days | The analysis population included all randomized participants, with missing values imputed as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Grade 0 Pain in the Study Eye by Visit. | 18 days | The analysis population included all randomized participants, with missing values imputed as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit. | 18 days | The analysis population included all randomized participants, with missing values imputed as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit. | 18 days | The analysis population included all randomized participants, with missing values imputed as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | Loteprednol Etabonate Gel (BID) | 38 | Participants | ||
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | Vehicle Gel (BID) | 29 | Participants | ||
| Percentage of Participants With Grade 0 Pain in the Study Eye. | Loteprednol Etabonate Gel (BID) | 120 | Participants | ||
| Percentage of Participants With Grade 0 Pain in the Study Eye. | Vehicle Gel (BID) | 97 | Participants | ||
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | Loteprednol Etabonate Gel (BID) | Day 3 | 16 | Participants | |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | Vehicle Gel (BID) | Day 3 | 11 | Participants | |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | Loteprednol Etabonate Gel (BID) | Day 15 | 82 | Participants | |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | Vehicle Gel (BID) | Day 15 | 57 | Participants | |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | Loteprednol Etabonate Gel (BID) | Day 18 | 80 | Participants | |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | Vehicle Gel (BID) | Day 18 | 67 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 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 Gel (BID) | 163 | |
| Overall Study | STARTED | Vehicle Gel (BID) | 163 | |
| Overall Study | COMPLETED | Loteprednol Etabonate Gel (BID) | 141 | |
| Overall Study | COMPLETED | Vehicle Gel (BID) | 107 | |
| Overall Study | NOT COMPLETED | Loteprednol Etabonate Gel (BID) | 22 | |
| Overall Study | NOT COMPLETED | Vehicle Gel (BID) | 56 |
Source ClinicalTrials.gov
Adverse events2
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 | Endophthalmitis | Eye disorders | Loteprednol Etabonate Gel (BID) | 0 | 162 | |
| serious | Endophthalmitis | Eye disorders | Vehicle Gel (BID) | 1 | 163 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Loteprednol Etabonate Gel (BID) | 0 | 162 |
| Total, all-cause mortality | Vehicle Gel (BID) | 0 | 163 |
| Total, other adverse events | Loteprednol Etabonate Gel (BID) | 0 | 162 |
| Total, other adverse events | Vehicle Gel (BID) | 0 | 163 |
| Total, serious adverse events | Loteprednol Etabonate Gel (BID) | 0 | 162 |
| Total, serious adverse events | Vehicle Gel (BID) | 1 | 163 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Loteprednol Etabonate Gel (BID) vs Vehicle Gel (BID): Percentage of Participants With Grade 0 Pain in the Study Eye. | Trial comparisons |
| Loteprednol Etabonate Gel (BID) vs Vehicle Gel (BID): Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | Trial comparisons |
| Loteprednol Etabonate Gel (BID) vs Vehicle Gel (BID): deaths from any cause | Trial comparisons |
| Loteprednol Etabonate Gel (BID) vs Vehicle Gel (BID): 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/NCT02208297
GET https://conductscience.org/api/trials/v1/NCT02208297/results?page=2