Trial · NCT02065375
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
NCT02065375, Phase 2, Completed, Biogen; results first posted 2023-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery. Trials, record NCT02065375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02065375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
- NCT number
- NCT02065375
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Inflammation and Pain Following Ocular Surgery
- Interventions
- Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%, Placebo
- First posted
- 2014-02-19
- Last updated
- 2025-06-03
- Results first posted
- 2023-04-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absence of Anterior Chamber Cells at Day 15 (Visit 5) | 15 days after the participant receives the first dose | Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. |
| Primary | Absence of Ocular Pain at Day 4 (Visit 3) | 4 days after the participant receives the first dose | Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absence of Anterior Chamber Cells at Day 15 (Visit 5) | 15 days after the participant receives the first dose | Intent-to-treat population (all randomized patients with available data). Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Absence of Ocular Pain at Day 4 (Visit 3) | 4 days after the participant receives the first dose | Intent-to-treat population (all randomized patients with available data). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Omaveloxolone Ophthalmic Suspension 1.0% | Yes | 10 | Participants | |
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Omaveloxolone Ophthalmic Suspension 0.5% | Yes | 12 | Participants | |
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Placebo | Yes | 11 | Participants | |
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Omaveloxolone Ophthalmic Suspension 1.0% | No | 27 | Participants | |
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Omaveloxolone Ophthalmic Suspension 0.5% | No | 21 | Participants | |
| Absence of Anterior Chamber Cells at Day 15 (Visit 5) | Placebo | No | 28 | Participants | |
| Absence of Ocular Pain at Day 4 (Visit 3) | Omaveloxolone Ophthalmic Suspension 1.0% | Yes | 11 | Participants | |
| Absence of Ocular Pain at Day 4 (Visit 3) | Omaveloxolone Ophthalmic Suspension 0.5% | Yes | 9 | Participants | |
| Absence of Ocular Pain at Day 4 (Visit 3) | Placebo | Yes | 20 | Participants | |
| Absence of Ocular Pain at Day 4 (Visit 3) | Omaveloxolone Ophthalmic Suspension 1.0% | No | 26 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omaveloxolone Ophthalmic Suspension 1.0% | 37 | |
| Overall Study | STARTED | Omaveloxolone Ophthalmic Suspension 0.5% | 33 | |
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | Completed Treatment | Omaveloxolone Ophthalmic Suspension 1.0% | 19 | |
| Overall Study | Completed Treatment | Omaveloxolone Ophthalmic Suspension 0.5% | 15 | |
| Overall Study | Completed Treatment | Placebo | 25 | |
| Overall Study | COMPLETED | Omaveloxolone Ophthalmic Suspension 1.0% | 37 | |
| Overall Study | COMPLETED | Omaveloxolone Ophthalmic Suspension 0.5% | 33 | |
| Overall Study | COMPLETED | Placebo | 39 | |
| Overall Study | NOT COMPLETED | Omaveloxolone Ophthalmic Suspension 1.0% | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events252
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 pigmentation | Eye disorders | Omaveloxolone Ophthalmic Suspension 1.0%: Study Eye | 1 | 37 | 1 |
| other | Anterior chamber pigmentation | Eye disorders | Omaveloxolone Ophthalmic Suspension 1.0%: Non-study Eye | 0 | 37 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Omaveloxolone Ophthalmic Suspension 0.5%: Study Eye | 0 | 33 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Omaveloxolone Ophthalmic Suspension 0.5%: Non-study Eye | 0 | 33 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Placebo: Study Eye | 0 | 39 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Placebo: Non-study Eye | 0 | 39 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Omaveloxolone Ophthalmic Suspension 1.0%: Non-ocular AE | 0 | 37 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Omaveloxolone Ophthalmic Suspension 0.5%: Non-ocular AE | 0 | 33 | 0 |
| other | Anterior chamber pigmentation | Eye disorders | Placebo: Non-ocular AE | 0 | 39 | 0 |
| other | Blepharitis | Eye disorders | Omaveloxolone Ophthalmic Suspension 1.0%: Study Eye | 0 | 37 | 0 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omaveloxolone Ophthalmic Suspension 1.0%: Study Eye | 0 | 37 |
| Total, all-cause mortality | Omaveloxolone Ophthalmic Suspension 1.0%: Non-study Eye | 0 | 37 |
| Total, all-cause mortality | Omaveloxolone Ophthalmic Suspension 0.5%: Study Eye | 0 | 33 |
| Total, all-cause mortality | Omaveloxolone Ophthalmic Suspension 0.5%: Non-study Eye | 0 | 33 |
| Total, all-cause mortality | Placebo: Study Eye | 0 | 39 |
| Total, all-cause mortality | Placebo: Non-study Eye | 0 | 39 |
| Total, all-cause mortality | Omaveloxolone Ophthalmic Suspension 1.0%: Non-ocular AE | 0 | 37 |
| Total, all-cause mortality | Omaveloxolone Ophthalmic Suspension 0.5%: Non-ocular AE | 0 | 33 |
| Total, all-cause mortality | Placebo: Non-ocular AE | 0 | 39 |
| Total, other adverse events | Omaveloxolone Ophthalmic Suspension 1.0%: Study Eye | 18 | 37 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
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/NCT02065375
GET https://conductscience.org/api/trials/v1/NCT02065375/events?page=2