Cataract in Inflammatory Ocular DisordersPhase 2NCT04711213
A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery
A Phase 2 study testing Dexamethasone Dose 1 and Dexamethasone Dose 2 in people with Cataract in Inflammatory Ocular Disorders, run by iDrop, Inc. at 1 site in El Salvador.
Trial summary
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract in Inflammatory Ocular Disorders
- What is being tested?
- Dexamethasone Dose 1 and Dexamethasone Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEl Salvador
- Study dates
- 14 Sep 2020to 15 Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing traditional cataract surgery.
Who cannot join
- Patients with unusual ocular conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.
Read the detailed description
"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.
- Being tested
- Dexamethasone Dose 1, Dexamethasone Dose 2, Placebo Dose 1, Placebo Dose 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Dose 1Drug
Dexamethasone ophthalmic suspension dose 1
Dexamethasone Dose 2Drug
Dexamethasone ophthalmic suspension dose 2
Placebo Dose 1Drug
Placebo suspension dose 1
Placebo Dose 2Drug
Placebo suspension dose 2
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Dose 1 | Active comparator | Not described Receives: Drug: Dexamethasone Dose 1 |
| Dexamethasone Dose 2 | Active comparator | Not described Receives: Drug: Dexamethasone Dose 2 |
| Placebo Dose 1 | Placebo comparator | Not described Receives: Drug: Placebo Dose 1 |
| Placebo Dose 2 | Placebo comparator | Not described Receives: Drug: Placebo Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular inflammation
Measuring Anterior Cell Count
Measured: Day 8
Secondary outcomes (1)
Ocular Pain
Measuring patient ocular pain using an 11-point visual scale
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start14 Sep 2020
- Primary completion31 Oct 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract in Inflammatory Ocular DisordersStudies of the same condition, open and under way.
- 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
- Model description
- Randomized to 2 active dosing groups and 2 corresponding dosing groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- iDrop, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Casada, MD, Principal investigator, President - Centre De. Oftalmolgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711213
- Sponsor's protocol ID
- C-02
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
- ClinicalTrials.gov ID
- NCT04711213
- Acronym / sponsor ID
- C-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- iDrop, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.
Detailed description
"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized to 2 active dosing groups and 2 corresponding dosing groups
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Dose 1 | Active comparator | Drug: Dexamethasone Dose 1 |
| Dexamethasone Dose 2 | Active comparator | Drug: Dexamethasone Dose 2 |
| Placebo Dose 1 | Placebo comparator | Drug: Placebo Dose 1 |
| Placebo Dose 2 | Placebo comparator | Drug: Placebo Dose 2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing traditional cataract surgery.
Key exclusion criteria (1 listed)
- Patients with unusual ocular conditions.
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 |
|---|---|---|
| Dexamethasone Dose 1Dexamethasone ophthalmic suspension dose 1 | Drug | Dexamethasone Dose 1 |
| Dexamethasone Dose 2Dexamethasone ophthalmic suspension dose 2 | Drug | Dexamethasone Dose 2 |
| Placebo Dose 1Placebo suspension dose 1 | Drug | Placebo Dose 1 |
| Placebo Dose 2Placebo suspension dose 2 | Drug | Placebo Dose 2 |
Primary outcome
Ocular inflammation
Time frame: Day 8
Measuring Anterior Cell Count
1 secondary outcome
Ocular Pain
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Recruiting
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
Macular Oedema, Cataract Surgery
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.
Gabriel Casada, MD principal investigator
President - Centre De. Oftalmolgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone Dose 1 and Dexamethasone Dose 2 in people with Cataract in Inflammatory Ocular Disorders, run by iDrop, Inc. at 1 site in El Salvador.
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 1 inclusion and 1 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ocular inflammation (time frame: Day 8). 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 15 Jan 2021.