Patient PreferencePhase 4NCT04549935
The PRIME Study: A Randomized, Controlled, Prospective Study
A Phase 4 study testing Dextenza and Topical Prednisolone in people with Patient Preference and Patient Outcomes, run by Vance Thompson Vision - MT at 1 site in United States.
Trial summary
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of… Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Preference, Patient Outcomes, Post-Operative Inflammation
- What is being tested?
- Dextenza and Topical Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 27 Aug 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Who cannot join
- Patients under the age of 22 or above the age of 75
- Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
- Patients with active infectious ocular or extraocular disease.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
- Paitents with know hypersensitivity to Dexamethasone
- Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
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- Patients with a history of ocular inflammation or macular edema
- Patients with allergy or inability to receive intracameral antibiotic
- Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
- Patient with a corticosteriod implant (i.e. Ozurdex).
- Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Briana Parker
Bozeman, Montana, 59718
Briana Parker, 406-599-5961, briana.parker@vancethompsonvision.com
Keeley Puls, 605 371-7075, kpuls@vancethompsonvision.com
About this study
Official title: A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Read the detailed description
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
- Conditions
- Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema
- Being tested
- Dextenza, Topical Prednisolone
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextenzaDrug
Dextenza 0.4mg
Topical PrednisoloneDrug
Standard of care topical drop treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A Dextenza | Active comparator | Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration. Receives: Drug: Dextenza |
| Group B Topical Prednisolone | Active comparator | Drug: Topical Prednisolone Standard of care topical drop treatment Receives: Drug: Topical Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)
Measured: Through Month 1
Secondary outcomes (7)
Percentage of eyes that have CME (Cystoid macular edema) post-operatively
Measured by OCT (Optical Coherence Tomography )
Measured: Through Month 1
Mean pain score per eye (Group A vs Group B)
Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Measured: Through Month 1
Incidence of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Measured: Through Month 1
Grade of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Measured: Through Month 1
Anterior chamber cell count
measured by SUN Working Group Grading Scheme
Measured: Through Month 1
Uncorrected Visual Acuity
measured by ETDRS chart a 4m
Measured: Through Month 1
Best Corrected Visual Acuity
measured by ETDRS chart a 4m
Measured: Through Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start14 Sep 2020 (estimated)
- Primary completion27 Aug 2021 (estimated)
- Study completion27 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PreferenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision - MT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549935
- Sponsor's protocol ID
- The PRIME Study
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 16 Sep 2020
- Results posted
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)
- ClinicalTrials.gov ID
- NCT04549935
- Acronym / sponsor ID
- The PRIME Study
- Conditions
- Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vance Thompson Vision - MTUniversity, hospital or other
- Study start
- 14 Sep 2020 (estimated)
- Primary completion
- 27 Aug 2021 (estimated)
- Study completion
- 27 Aug 2021 (estimated)
- First posted
- 16 Sep 2020 (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.
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Detailed description
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Dextenza | Active comparator | Drug: DextenzaDrug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration. |
| Group B Topical Prednisolone | Active comparator | Drug: Topical PrednisoloneDrug: Topical Prednisolone Standard of care topical drop treatment |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Key exclusion criteria (11 listed)
- Patients under the age of 22 or above the age of 75
- Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
- Patients with active infectious ocular or extraocular disease.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
- Paitents with know hypersensitivity to Dexamethasone
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 |
|---|---|---|
| DextenzaDextenza 0.4mg | Drug | Group A Dextenza |
| Topical PrednisoloneStandard of care topical drop treatment | Drug | Group B Topical Prednisolone |
Primary outcome
Patient Preference
Time frame: Through Month 1
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)
7 secondary outcomes
Percentage of eyes that have CME (Cystoid macular edema) post-operatively
Time frame: Through Month 1
Mean pain score per eye (Group A vs Group B)
Time frame: Through Month 1
Incidence of post-operative corneal haze
Time frame: Through Month 1
Grade of post-operative corneal haze
Time frame: Through Month 1
Anterior chamber cell count
Time frame: Through Month 1
Uncorrected Visual Acuity
Time frame: Through Month 1
Best Corrected Visual Acuity
Time frame: Through Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza and Topical Prednisolone in people with Patient Preference and Patient Outcomes, run by Vance Thompson Vision - MT 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Sep 2020. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Preference (time frame: Through Month 1). 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 16 Sep 2020.