Refractive SurgeryPhase 4AtLASNCT04281862
DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Topical Prednisolone in people with Refractive Surgery, run by Vance Thompson Vision at 1 site in United States.
Trial summary
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Surgery
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert 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
- 23 Jan 2020to 1 May 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult patient who is planned to undergo bilateral LASIK surgery.
- Refractive error between the 2 eyes of 2 Diopters or less
- 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 18.
- Patients who choose to have monovision after LASIK
- Patients with corneal pathology that may interfere with LASIK outcomes
- Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
- Active infectious ocular or systemic disease.
- Patients with active infectious ocular or extraocular disease.
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- Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- Patients with known hypersensitivity to Dexamethasone.
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
- Patients with a history of ocular inflammation or macular edema.
- Patients with allergy or inability to receive topical antibiotic.
- Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
- Patients with a corticosteroid implant (i.e. Ozurdex).
- 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
- History of cauterization of the punctum
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision ND
West Fargo, North Dakota, 58078
Sarah Thiede, 701-566-5390, sarah.thiede@vancethompsonvision.com
Jake Hutchison, 701-566-5390, jake.hutchison@vancethompsonvision.com
About this study
Official title: DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.
Read the detailed description
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week.
Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.
- Conditions
- Refractive Surgery
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
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 the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Topical PrednisoloneDrug
Standard of care topical drop treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dextenza Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Group B | Active comparator | Topical Prednisolone 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 COMTOL adapted survey.
Measured: Through Month 1 (Day 28 +/- 3 days)
Patient Comfort
As measured by SPEED Questionnaire.
Measured: Through Month 1 (Day 28 +/- 3 days)
Secondary outcomes (3)
Ocular Surface Health
As measured by corneal staining.
Measured: Through Month 1 (Day 28 +/- 3 days)
Visual Outcomes
As measured by uncorrected Visual Acuity.
Measured: Through Month 1 (Day 28 +/- 3 days)
Ocular Pain
As measured by Ocular Pain Assessment.
Measured: Through Month 1 (Day 28 +/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start23 Jan 2020
- Primary completion1 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive SurgeryStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281862
- Sponsor's protocol ID
- ATLAS2020
- Acronym
- AtLAS
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
- ClinicalTrials.gov ID
- NCT04281862
- Acronym / sponsor ID
- AtLAS / ATLAS2020
- Conditions
- Refractive Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 24 Feb 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 determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.
Detailed description
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week.
Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertDextenza |
| Group B | Active comparator | Drug: Topical PrednisoloneTopical Prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any adult patient who is planned to undergo bilateral LASIK surgery.
- Refractive error between the 2 eyes of 2 Diopters or less
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Key exclusion criteria (19 listed)
- Patients under the age of 18.
- Patients who choose to have monovision after LASIK
- Patients with corneal pathology that may interfere with LASIK outcomes
- Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
- Active infectious ocular or systemic disease.
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 |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic InsertThe 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 the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration. | Drug | Group A |
| Topical PrednisoloneStandard of care topical drop treatment | Drug | Group B |
Primary outcome
Patient Preference
Time frame: Through Month 1 (Day 28 +/- 3 days)
As measured by COMTOL adapted survey.
Patient Comfort
Time frame: Through Month 1 (Day 28 +/- 3 days)
As measured by SPEED Questionnaire.
3 secondary outcomes
Ocular Surface Health
Time frame: Through Month 1 (Day 28 +/- 3 days)
Visual Outcomes
Time frame: Through Month 1 (Day 28 +/- 3 days)
Ocular Pain
Time frame: Through Month 1 (Day 28 +/- 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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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.
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 0.4Mg Ophthalmic Insert and Topical Prednisolone in people with Refractive Surgery, run by Vance Thompson Vision 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 19 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: status not confirmed, as of the sponsor's last update on 24 Feb 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?
Results are not available in the source record.
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 (Day 28 +/- 3 days)). The study lists 2 primary outcomes in all. 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 24 Feb 2020.