CataractPhase 1NCT01605942
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
A Phase 1 study testing Dexamethasone Drug Delivery System in people with Cataract, run by Allergan at 1 site in United States.
Trial summary
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Dexamethasone Drug Delivery System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2012
- Phase
- Phase 1
- 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
- Planned single cataract extraction with lens implant
- Best-corrected visual acuity of 20/200 or better in the opposite eye
Who cannot join
- Glaucoma or history of intraocular hypertension in the study eye
- History of chronic ocular allergy in the last year requiring treatment
- Scheduled for cataract surgery in the non-study eye during study participation
Trial locations and contacts
1 site in 1 country.
About this study
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.
- Conditions
- Cataract
- Being tested
- Dexamethasone Drug Delivery System, Placebo Drug Delivery System
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Drug Delivery SystemDrug
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Drug Delivery SystemDrug
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Drug Delivery System | Experimental | Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. Receives: Drug: Dexamethasone Drug Delivery System |
| Placebo Drug Delivery System | Placebo comparator | Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. Receives: Drug: Placebo Drug Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Clearance of Anterior Chamber Inflammation
The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).
Measured: Up to Day 71
Secondary outcomes (1)
Plasma Levels of Dexamethasone
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Measured: Day 2, Day 7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Study terminated due to corporate decision.
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 CataractStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605942
- Sponsor's protocol ID
- 206207-027
- Status last verified
- Jun 2015
- First submitted
- 23 May 2012
- Last updated
- 1 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
- ClinicalTrials.gov ID
- NCT01605942
- Acronym / sponsor ID
- 206207-027
- Conditions
- Cataract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to corporate decision.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 1 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Drug Delivery System | Experimental | Drug: Dexamethasone Drug Delivery SystemDexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
| Placebo Drug Delivery System | Placebo comparator | Drug: Placebo Drug Delivery SystemPlacebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned single cataract extraction with lens implant
- Best-corrected visual acuity of 20/200 or better in the opposite eye
Key exclusion criteria (3 listed)
- Glaucoma or history of intraocular hypertension in the study eye
- History of chronic ocular allergy in the last year requiring treatment
- Scheduled for cataract surgery in the non-study eye during study participation
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 Drug Delivery SystemDexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | Drug | Dexamethasone Drug Delivery System |
| Placebo Drug Delivery SystemPlacebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | Drug | Placebo Drug Delivery System |
Primary outcome
Number of Patients With Clearance of Anterior Chamber Inflammation
Time frame: Up to Day 71
The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).
1 secondary outcome
Plasma Levels of Dexamethasone
Time frame: Day 2, Day 7, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone Drug Delivery System in people with Cataract, run by Allergan at 1 site 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Jul 2015. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 1 Jul 2015). 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?
Number of Patients With Clearance of Anterior Chamber Inflammation (time frame: Up to Day 71). 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 1 Jul 2015.