CataractPhase 4NCT04479748
DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses
A Phase 4 study testing Dexamethasone and Prednisolone Acetate 1% Oph Susp in people with Cataract, run by Prism Vision Group at 1 site in United States.
Trial summary
The investigators seek to assess the effect of pre-operative and continued post-operative corticosteroid use on pain, patient preference, visual outcomes, and change in objective quantifiable biological parameters in patients undergoing bilateral cataract surgery with premium intraocular lens implantation with or… 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 and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 12 Dec 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age 18 or greater with plans to undergo bilateral clear cornea cataract surgery with phacoemulsification and implantation of a premium posterior chamber IOL
- Schirmer's test score (anesthetized) ≥ 5 mm at Screening in either eye.
- TBUT ≤ 7 seconds at Screening or Baseline in either eye.
- All subjects must provide signed written consent prior to participation in any study-related procedures. Able to comply with study requirements and visit schedule.
Who cannot join
- revious corneal surgery or pathology
- Active or history of chronic or recurrent inflammatory eye disease in either eye
- Ocular pain in either eye
- Proliferative diabetic retinopathy in either eye
- Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
- Laser or incisional ocular surgery during the study period and 6 months prior in either eye
Show all 20Show fewer
- Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted)
- Chronic daily use (defined as > 7 consecutive days at the recommended dosing frequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia, rheumatoid arthritis, etc.) during the study period.
- Ophthalmic artificial tear drop use within 2 hours prior to any study visit. Any OTC artificial tear (preserved or unpreserved) should be continued at the same frequency and with no change in drop brand.
- Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidal anti- inflammatory drugs [NSAIDs], anti-glaucoma medications within 7 days or during study period
- Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- Corticosteroids (intranasal, inhaled, topical dermatological, and perianal steroids) within 30 days prior to entry in the study are not permitted
- Pregnant or breast-feeding women, women who wish to become pregnant during the length of study participation, or women of child-bearing potential.
- Use of systemic NSAID greater than 375 mg per day.
- Glaucoma or is on medications to treat glaucoma.
- Ocular Hypertension, defined as IOP of >21 mmHg, is on medications to treat hypertension or has a history of IOP spikes in either eye including steroid-related IOP increases.
- Presence of nasolacrimal duct obstruction or history of cauterization of the Punctum.
- Active epiphora or clinically significant dry eye syndrome.
- Know allergy or sensitivity to the investigational product or its components.
- The Investigator determines that the subject should not be included for reasons not already specified (e.g, systemic or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Associates of Vineland
Vineland, New Jersey, 08361
About this study
The investigators seek to assess the effect of pre-operative and continued post-operative corticosteroid use on pain, patient preference, visual outcomes, and change in objective quantifiable biological parameters in patients undergoing bilateral cataract surgery with premium intraocular lens implantation with or without baseline ocular surface disease.
Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.
- Conditions
- Cataract
- Being tested
- Dexamethasone, Prednisolone Acetate 1% Oph Susp
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Treatment of pain and inflammation following ophthalmic surgery
Prednisolone Acetate 1% Oph SuspDrug
Topical steroid
| Study group | Role | What they receive |
|---|---|---|
| Dextenza insert | Other | Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). Receives: Drug: Dexamethasone |
| Fellow-eye | Other | The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics. Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale
Proportion of eyes with absence of pain as measured by pain scale (pain score = 0) from Baseline over each time point through Day 30.
Subjects will use the Ocular Pain Assessment scale. A 0-10 point scale, where 0 is the least pain and 10 is the greatest pain, subjects will be asked to rank their level of pain.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Oct 2020
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prism Vision Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sydney Tyson, Prism Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479748
- Sponsor's protocol ID
- DEXTENZA
- Status last verified
- Jun 2023
- First submitted
- 16 Jul 2020
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses
- ClinicalTrials.gov ID
- NCT04479748
- Acronym / sponsor ID
- DEXTENZA
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Prism Vision GroupUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 21 Jul 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.
The investigators seek to assess the effect of pre-operative and continued post-operative corticosteroid use on pain, patient preference, visual outcomes, and change in objective quantifiable biological parameters in patients undergoing bilateral cataract surgery with premium intraocular lens implantation with or without baseline ocular surface disease.
Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextenza insert | Other | Drug: DexamethasonePatient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). |
| Fellow-eye | Other | Drug: Prednisolone Acetate 1% Oph SuspThe fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age 18 or greater with plans to undergo bilateral clear cornea cataract surgery with phacoemulsification and implantation of a premium posterior chamber IOL
Key exclusion criteria (20 listed)
- revious corneal surgery or pathology
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 |
|---|---|---|
| DexamethasoneTreatment of pain and inflammation following ophthalmic surgery | Drug | Dextenza insert |
| Prednisolone Acetate 1% Oph SuspTopical steroid | Drug | Fellow-eye |
Primary outcome
Pain Scale
Time frame: 30 days
Proportion of eyes with absence of pain as measured by pain scale (pain score = 0) from Baseline over each time point through Day 30. Subjects will use the Ocular Pain Assessment scale. A 0-10 point scale, where 0 is the least pain and 10 is the greatest pain, subjects will be asked to rank their level of pain.
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 22 Jun 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dexamethasone and Prednisolone Acetate 1% Oph Susp in people with Cataract, run by Prism Vision Group 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 4 inclusion and 20 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 22 Jun 2023. 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?
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?
Pain Scale (time frame: 30 days). 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 22 Jun 2023.