Trial · NCT02793817
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
NCT02793817, Phase 3, Completed, Kala Pharmaceuticals, Inc.; results first posted 2019-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain. Trials, record NCT02793817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02793817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
- NCT number
- NCT02793817
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 520 participants, actual
- Lead sponsor
- Kala Pharmaceuticals, Inc.
- Conditions
- Post Surgical Ocular Inflammation and Pain
- Interventions
- KPI-121 1% Ophthalmic Suspension dosed BID, Vehicle of KPI-121 Ophthalmic Suspension dosed BID
- First posted
- 2016-06-08
- Last updated
- 2020-12-16
- Results first posted
- 2019-04-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Resolution of Anterior Chamber (AC) Cells at Day 8 | Visit 5 (Day 8) maintained through Visit 6 (Day 15) | Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells |
| Primary | Complete Resolution of Ocular Pain at Day 8 | Visit 5 (Day 8) maintained through Visit 6 (Day 15) | Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe |
| Secondary | Complete Resolution of Ocular Pain at Day 4 | Visit 4 (Day 4) maintained through Visit 6 (Day 15) | Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe |
| Secondary | Complete Resolution of Anterior Chamber (AC) Flare at Day 4 | Visit 4 (Day 4) maintained through Visit 6 (Day 15) | Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None 1. = Mild (trace to clearly noticeable, visible) 2. = Moderate (without plastic aqueous humor) 3. = Marked (with plastic aqueous humor) 4. = Severe (with fibrin deposits and/or clots) |
| Secondary | Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 | Visit 1 (Baseline) and Visit 4 (Day 4) | The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Resolution of Anterior Chamber (AC) Cells at Day 8 | Visit 5 (Day 8) maintained through Visit 6 (Day 15) | Intent to Treat - All subjects randomized | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Complete Resolution of Ocular Pain at Day 8 | Visit 5 (Day 8) maintained through Visit 6 (Day 15) | Intent to Treat - All subjects randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Resolution of Ocular Pain at Day 4 | Visit 4 (Day 4) maintained through Visit 6 (Day 15) | Intent to Treat - All subjects randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Resolution of Anterior Chamber (AC) Flare at Day 4 | Visit 4 (Day 4) maintained through Visit 6 (Day 15) | Intent to Treat - All subjects randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 | Visit 1 (Baseline) and Visit 4 (Day 4) | Intent to Treat - All subjects randomized | score on a scale | MEAN |
| POST_HOC | Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 8 | Visit 1 (Baseline) and Visit 5 (Day 8) | Intent to Treat - All subjects randomized | score on a scale | MEAN |
| POST_HOC | Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 15 | Visit 1 (Baseline) and Visit 6 (Day 15) | Intent to Treat - All subjects randomized | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Resolution of Anterior Chamber (AC) Cells at Day 8 | KPI-121 1% Ophthalmic Suspension | 54 | Participants | ||
| Complete Resolution of Anterior Chamber (AC) Cells at Day 8 | Vehicle of KPI-121 1% Ophthalmic Suspension | 32 | Participants | ||
| Complete Resolution of Ocular Pain at Day 8 | KPI-121 1% Ophthalmic Suspension | 149 | Participants | ||
| Complete Resolution of Ocular Pain at Day 8 | Vehicle of KPI-121 1% Ophthalmic Suspension | 96 | Participants | ||
| Complete Resolution of Ocular Pain at Day 4 | KPI-121 1% Ophthalmic Suspension | 109 | Participants | ||
| Complete Resolution of Ocular Pain at Day 4 | Vehicle of KPI-121 1% Ophthalmic Suspension | 64 | Participants | ||
| Complete Resolution of Anterior Chamber (AC) Flare at Day 4 | KPI-121 1% Ophthalmic Suspension | 113 | Participants | ||
| Complete Resolution of Anterior Chamber (AC) Flare at Day 4 | Vehicle of KPI-121 1% Ophthalmic Suspension | 63 | Participants | ||
| Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 | KPI-121 1% Ophthalmic Suspension | -0.7 | Standard Deviation 0.84 | score on a scale | |
| Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 | Vehicle of KPI-121 1% Ophthalmic Suspension | -0.5 | Standard Deviation 0.91 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KPI-121 1.0% Ophthalmic Suspension | 261 | |
| Overall Study | STARTED | Vehicle of KPI-121 Ophthalmic Suspension | 259 | |
| Overall Study | COMPLETED | KPI-121 1.0% Ophthalmic Suspension | 258 | |
| Overall Study | COMPLETED | Vehicle of KPI-121 Ophthalmic Suspension | 254 | |
| Overall Study | NOT COMPLETED | KPI-121 1.0% Ophthalmic Suspension | 3 | |
| Overall Study | NOT COMPLETED | Vehicle of KPI-121 Ophthalmic Suspension | 5 |
Source ClinicalTrials.gov
Adverse events20
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 | Cystoid macular oedema | Eye disorders | KPI-121 1% Ophthalmic Suspension | 3 | 261 | 3 |
| other | Cystoid macular oedema | Eye disorders | Vehicle of KPI-121 1% Ophthalmic Suspension | 3 | 259 | 4 |
| other | Eye pain | Eye disorders | KPI-121 1% Ophthalmic Suspension | 3 | 261 | 3 |
| other | Eye pain | Eye disorders | Vehicle of KPI-121 1% Ophthalmic Suspension | 6 | 259 | 6 |
| other | Posterior capsule opacification | Eye disorders | KPI-121 1% Ophthalmic Suspension | 3 | 261 | 3 |
| other | Posterior capsule opacification | Eye disorders | Vehicle of KPI-121 1% Ophthalmic Suspension | 4 | 259 | 4 |
| other | Instilation site pain | General disorders | KPI-121 1% Ophthalmic Suspension | 1 | 261 | 2 |
| other | Instilation site pain | General disorders | Vehicle of KPI-121 1% Ophthalmic Suspension | 3 | 259 | 4 |
| other | Nasopharyngitis | Infections and infestations | KPI-121 1% Ophthalmic Suspension | 4 | 261 | 4 |
| other | Nasopharyngitis | Infections and infestations | Vehicle of KPI-121 1% Ophthalmic Suspension | 1 | 259 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KPI-121 1% Ophthalmic Suspension | 0 | 261 |
| Total, all-cause mortality | Vehicle of KPI-121 1% Ophthalmic Suspension | 0 | 259 |
| Total, other adverse events | KPI-121 1% Ophthalmic Suspension | 18 | 261 |
| Total, other adverse events | Vehicle of KPI-121 1% Ophthalmic Suspension | 21 | 259 |
| Total, serious adverse events | KPI-121 1% Ophthalmic Suspension | 1 | 261 |
| Total, serious adverse events | Vehicle of KPI-121 1% Ophthalmic Suspension | 2 | 259 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KPI-121 1% Ophthalmic Suspension vs Vehicle of KPI-121 1% Ophthalmic Suspension: Complete Resolution of Anterior Chamber (AC) Flare at Day 4 | Trial comparisons |
| KPI-121 1% Ophthalmic Suspension vs Vehicle of KPI-121 1% Ophthalmic Suspension: Complete Resolution of Ocular Pain at Day 8 | Trial comparisons |
| KPI-121 1% Ophthalmic Suspension vs Vehicle of KPI-121 1% Ophthalmic Suspension: Complete Resolution of Ocular Pain at Day 4 | Trial comparisons |
| KPI-121 1% Ophthalmic Suspension vs Vehicle of KPI-121 1% Ophthalmic Suspension: deaths from any cause | Trial comparisons |
| KPI-121 1% Ophthalmic Suspension vs Vehicle of KPI-121 1% Ophthalmic Suspension: Complete Resolution of Anterior Chamber (AC) Cells at Day 8 | Trial comparisons |
| KPI-121 1% Ophthalmic Suspension vs Vehicle of KPI-121 1% Ophthalmic Suspension: 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/NCT02793817
GET https://conductscience.org/api/trials/v1/NCT02793817/registered