Inflammation and Pain Following Ocular SurgeryPhase 2NCT02065375
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
A Phase 2 study testing Omaveloxolone Ophthalmic Suspension 1.0% and Omaveloxolone Opthalmic Suspension 0.5% in people with Inflammation and Pain Following Ocular Surgery, run by Biogen at 6 sites in United States.
Trial summary
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation and Pain Following Ocular Surgery
- What is being tested?
- Omaveloxolone Ophthalmic Suspension 1.0% and Omaveloxolone Opthalmic Suspension 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Feb 2014to 30 Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be greater than or equal to 18 years of age of either sex or any race;
- Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
- Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
- Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;
Who cannot join
- Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
- Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
- Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
- Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
- Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
- Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye;
- Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Austin, Texas, 78731
Study site
Elizabeth City, North Carolina, 27909
Study site
Fort Myers, Florida, 33907
Study site
Garden Grove, California, 92843
Study site
Houston, Texas, 75022
Study site
Kansas City, Missouri, 64133
About this study
Official title: A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
Read the detailed description
Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
- Being tested
- Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%, Placebo
- Keywords
- RTA 408, Ocular surgery, Cataract surgery, Ocular inflammation, Ocular pain, Eye inflammation, omaveloxolone
- Medical subject headings
- Inflammation, Eye Pain, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omaveloxolone Ophthalmic Suspension 1.0%Drug
Also called RTA 408
Omaveloxolone Opthalmic Suspension 0.5%Drug
Also called RTA 408
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Omaveloxolone Ophthalmic Suspension 1.0% | Experimental | Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Receives: Drug: Omaveloxolone Ophthalmic Suspension 1.0% |
| Omaveloxolone Ophthalmic Suspension 0.5% | Experimental | Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Receives: Drug: Omaveloxolone Opthalmic Suspension 0.5% |
| Placebo | Placebo comparator | Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Anterior Chamber Cells at Day 15 (Visit 5)
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.
Measured: 15 days after the participant receives the first dose
Absence of Ocular Pain at Day 4 (Visit 3)
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.
Measured: 4 days after the participant receives the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start28 Feb 2014
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammation and Pain Following Ocular SurgeryStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065375
- Sponsor's protocol ID
- RTA 408-C-1307
- Status last verified
- May 2025
- First submitted
- 13 Feb 2014
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
- ClinicalTrials.gov ID
- NCT02065375
- Acronym / sponsor ID
- RTA 408-C-1307
- Keywords
- RTA 408, Ocular surgery, Cataract surgery, Ocular inflammation, Ocular pain, Eye inflammation, omaveloxolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 28 Feb 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 19 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
Detailed description
Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omaveloxolone Ophthalmic Suspension 1.0% | Experimental | Drug: Omaveloxolone Ophthalmic Suspension 1.0%Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery |
| Omaveloxolone Ophthalmic Suspension 0.5% | Experimental | Drug: Omaveloxolone Opthalmic Suspension 0.5%Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be greater than or equal to 18 years of age of either sex or any race;
- Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
- Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
- Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;
Key exclusion criteria (7 listed)
- Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
- Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
- Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
- Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
- Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omaveloxolone Ophthalmic Suspension 1.0%Also: RTA 408 | Drug | Omaveloxolone Ophthalmic Suspension 1.0% |
| Omaveloxolone Opthalmic Suspension 0.5%Also: RTA 408 | Drug | Omaveloxolone Ophthalmic Suspension 0.5% |
| Placebo | Drug | Placebo |
Primary outcome
Absence of Anterior Chamber Cells at Day 15 (Visit 5)
Time frame: 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.
Absence of Ocular Pain at Day 4 (Visit 3)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omaveloxolone Ophthalmic Suspension 1.0% and Omaveloxolone Opthalmic Suspension 0.5% in people with Inflammation and Pain Following Ocular Surgery, run by Biogen at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Anterior Chamber Cells at Day 15 (Visit 5) (time frame: 15 days after the participant receives the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.