Intraocular Lens Associated Postoperative InflammationPhase 4NCT02819908
Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery
A Phase 4 study testing Imprimis Dropless and Imprimis Less Drops in people with Intraocular Lens Associated Postoperative Inflammation, run by Eye Center of North Florida at 1 site in United States.
Trial summary
To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens Associated Postoperative Inflammation
- What is being tested?
- Imprimis Dropless and Imprimis Less Drops
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Apr 2016
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ocular criteria must be met in both eyes.
- Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.
- Gender: Males and Females.
- Age: 21 or older.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
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- Willing and able to administer eye drops and record the times the drops were instilled.
- Scheduled to undergo standard cataract surgery or refractive lens exchange with topical anesthesia in both eyes within 6-15 days of each other.
- Potential postoperative best-corrected visual acuity of 20/30 or better.
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Presence of epiretinal membrane.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
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- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous refractive surgery.
- Anesthesia other than topical, oral or intravenous anesthesia (i.e. retrobulbar, general, etc).
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- If any of the following exclusion criteria are applicable to the study eye, the subject should not continue in the study.
- If full dose (0.2 cc) is not delivered into the vitreous through the zonules as evaluated by surgeon's direct visualization of the material in the posterior chamber with lack of material in the anterior chamber and an empty syringe.
- Significant vitreous loss.
- Significant anterior chamber hyphema.
- Uncontrollable intraocular pressure.
- Zonular or capsular rupture.
- Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.
- Suturing of incision required at time of surgery.
- Intraocular lens tilt or decentration
- Peri-bulbar or retro-bulbar block required during surgery.
- Other procedure, such as pupil stretch, expanders, iris hooks during surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Center of North Florida
Panama City, Florida, 32409
About this study
To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).
The hypothesis is that the "dropless" regimen will be non-inferior to the "less drops" regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.
Read the detailed description
Modern cataract surgery has become a relatively short out-patient procedure with small incisions and short post-operative recovery time. Surgery can be influenced by surgical technique and experience. Prophylactic pharmaceutical regimens are designed to control post-operative pain and to reduce the potential for inflammation (i.e. macular edema, CME) and infection (i.e. endophthalmitis).
The most serious potential infection related to cataract surgery is endophthalmitis. Endophthalmitis is a result of microorganisms entering the eye, either during the surgical procedure or before surgical incisions have healed completely. The risk of infection can be reduced in several ways. Pre-operatively, reducing the bacteria on the cornea and ocular adnexa can be helpful. During surgery, appropriate technique can reduce the potential for ingress. Post-operatively, prophylactic antibiotics can eliminate organisms once they have entered the eye. Topical drops, intracameral antibiotics and subconjunctival injections are typical options in current use, usually selected on the basis of spectrum of coverage, cost, efficacy and/or expected side effects.
With regard to inflammation, one of the most common post-operative responses is cystoid macular edema (CME). Steroids and non-steroidal anti-inflammatory drugs (NSAIDs) appear effective in reducing the incidence of CME, with NSAIDs posing a lower risk for IOP spikes and showing greater efficacy some studies.
While there is documented evidence of the utility of prophylactic post-operative treatment for pain and infection, patient compliance remains a significant concern. The regimen is often complex, with multiple drops several times per day. Inability to instill the drops, forgetfulness and a lack of appreciation for the importance of compliance can all be contributing factors.
There are several new options to try to address the potential issues related to poor patient compliance. One is referred to as "dropless" cataract surgery, which involves injection of a multi-drug compound into the eye at time of cataract surgery; one such compound includes triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (TriMoxiVanc). Another alternative is to reduce the burden of the pharmaceutical regimen using a compounded topical medication; this is termed "less drops" cataract surgery. An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week post-operatively followed by a topical formulation of prednisolone acetate and ketorolac tromethamine (PredKeterolac) given for weeks 2 to 4 after surgery.
The purpose of this study is to evaluate the differences in performance between the dropless and less-drops pharmaceutical regimens after cataract surgery.
- Being tested
- Imprimis Dropless, Imprimis Less Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imprimis DroplessDrug
Tri-Moxi-Vanc transzonular intravitreal injection
Imprimis Less DropsDrug
Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Imprimis Dropless | Active comparator | TriMoxiVanc 0.2cc intravitreal one time Receives: Drug: Imprimis Dropless |
| Imprimis Less Drops | Active comparator | Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Receives: Drug: Imprimis Less Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Intraocular Pressure (IOP) From Baseline
Based on Goldmann tonometry
Measured: To end of study (1 month postop)
Secondary outcomes (2)
Change in Corneal Thickness
Based on corneal pachymetry
Measured: To end of study (1 month postop)
Slit Lamp (Cornea Exam)
Measured: To end of study (1 month postop)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
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 Intraocular Lens Associated Postoperative InflammationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Center of North Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret L. Fisher, M.D., Eye Center of North Florida
- Investigators
- Bret L Fisher, MD, Principal investigator, Eye Center of North Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819908
- Sponsor's protocol ID
- BF-2015-011
- Status last verified
- Feb 2020
- First submitted
- 2 Sep 2015
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery
- ClinicalTrials.gov ID
- NCT02819908
- Acronym / sponsor ID
- BF-2015-011
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eye Center of North FloridaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 9 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).
The hypothesis is that the "dropless" regimen will be non-inferior to the "less drops" regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.
Detailed description
Modern cataract surgery has become a relatively short out-patient procedure with small incisions and short post-operative recovery time. Surgery can be influenced by surgical technique and experience. Prophylactic pharmaceutical regimens are designed to control post-operative pain and to reduce the potential for inflammation (i.e. macular edema, CME) and infection (i.e. endophthalmitis).
The most serious potential infection related to cataract surgery is endophthalmitis. Endophthalmitis is a result of microorganisms entering the eye, either during the surgical procedure or before surgical incisions have healed completely. The risk of infection can be reduced in several ways. Pre-operatively, reducing the bacteria on the cornea and ocular adnexa can be helpful. During surgery, appropriate technique can reduce the potential for ingress. Post-operatively, prophylactic antibiotics can eliminate organisms once they have entered the eye. Topical drops, intracameral antibiotics and subconjunctival injections are typical options in current use, usually selected on the basis of spectrum of coverage, cost, efficacy and/or expected side effects.
With regard to inflammation, one of the most common post-operative responses is cystoid macular edema (CME). Steroids and non-steroidal anti-inflammatory drugs (NSAIDs) appear effective in reducing the incidence of CME, with NSAIDs posing a lower risk for IOP spikes and showing greater efficacy some studies.
While there is documented evidence of the utility of prophylactic post-operative treatment for pain and infection, patient compliance remains a significant concern. The regimen is often complex, with multiple drops several times per day. Inability to instill the drops, forgetfulness and a lack of appreciation for the importance of compliance can all be contributing factors.
There are several new options to try to address the potential issues related to poor patient compliance. One is referred to as "dropless" cataract surgery, which involves injection of a multi-drug compound into the eye at time of cataract surgery; one such compound includes triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (TriMoxiVanc). Another alternative is to reduce the burden of the pharmaceutical regimen using a compounded topical medication; this is termed "less drops" cataract surgery. An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week post-operatively followed by a topical formulation of prednisolone acetate and ketorolac tromethamine (PredKeterolac) given for weeks 2 to 4 after surgery.
The purpose of this study is to evaluate the differences in performance between the dropless and less-drops pharmaceutical regimens after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imprimis Dropless | Active comparator | Drug: Imprimis DroplessTriMoxiVanc 0.2cc intravitreal one time |
| Imprimis Less Drops | Active comparator | Drug: Imprimis Less DropsPred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ocular criteria must be met in both eyes.
- Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.
- Gender: Males and Females.
- Age: 21 or older.
- Willing and able to provide written informed consent for participation in the study.
Key exclusion criteria (27 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Presence of epiretinal membrane.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
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 |
|---|---|---|
| Imprimis DroplessTri-Moxi-Vanc transzonular intravitreal injection | Drug | Imprimis Dropless |
| Imprimis Less DropsPred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively | Drug | Imprimis Less Drops |
Primary outcome
The Change in Intraocular Pressure (IOP) From Baseline
Time frame: To end of study (1 month postop)
Based on Goldmann tonometry
2 secondary outcomes
Change in Corneal Thickness
Time frame: To end of study (1 month postop)
Slit Lamp (Cornea Exam)
Time frame: To end of study (1 month postop)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Intraocular Lens Associated Postoperative Inflammation
RecruitingObservational study
Intraocular Lens Implant Registry Study
Intraocular Lens Complication, Intraocular Lens Rotation
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.
Bret L Fisher, MD principal investigator
Eye Center of North Florida
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 Imprimis Dropless and Imprimis Less Drops in people with Intraocular Lens Associated Postoperative Inflammation, run by Eye Center of North Florida 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 9 inclusion and 27 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 9 Mar 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?
Yes. Results are posted in the registry (first posted 9 Mar 2020). 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?
The Change in Intraocular Pressure (IOP) From Baseline (time frame: To end of study (1 month postop)). 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 9 Mar 2020.