Refractive SurgeryPhase 4NCT04396990
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
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 PRK 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
- 8 Jun 2020to 28 Sep 2020
- 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 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 PRK surgery.
- 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 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.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- Patients with known hypersensitivity to Dexamethasone.
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- 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 intracameral antibiotic.
- Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
- Patients with a corticosteroid implant (i.e. Ozurdex).
- Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes.
- Patients who do not have 20/20 snellen visual acuity potential pre-operatively.
- MRSE greater than 6 diopters.
- Greater than 2 diopters anisometropia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK
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 PRK surgery.
Read the detailed description
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.
- 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 Dextenza | Experimental | Will receive Dextenza post-operative Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Group B Topical Prednisolone | Active comparator | Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week Receives: Drug: Topical Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
Measured: Through Month 1 (Day 28 +/- 3 days)
Secondary outcomes (6)
Percentage of Eyes Epithelialized at Day 3
The percentage of eyes with fully healed epithelium at post-op day 3
Measured: Post-Operative Day 3
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative
The percentage of eyes with fully healed epithelium at day 4 post-operative
Measured: Postoperative Day 4
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)
Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain.
Measured: Day 3
SPEED Questionnaire Results at Baseline and Postoperative Day 28
Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe.
Measured: Pre-op Visit and Month 1 (Day 28)
Uncorrected Distance Visual Acuity
measured using the ETDRS acuity chart at 4 meters recorded in logMAR.
Measured: Month 1 and Month 3.
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative
Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation
Measured: Month 1 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start8 Jun 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
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 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Tiffany Facile, Vance Thompson Vision
- Investigators
- John Berdahl, MD, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396990
- Sponsor's protocol ID
- The RESTORE Study
- Status last verified
- Jul 2024
- First submitted
- 15 May 2020
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK
- ClinicalTrials.gov ID
- NCT04396990
- Acronym / sponsor ID
- The RESTORE Study
- Conditions
- Refractive Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 1 Aug 2023
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 PRK surgery.
Detailed description
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.
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 | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertWill receive Dextenza post-operative |
| Group B Topical Prednisolone | Active comparator | Drug: Topical PrednisoloneWill receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any adult patient who is planned to undergo bilateral PRK surgery.
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Key exclusion criteria (15 listed)
- Patients under the age of 18.
- 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.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
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 Dextenza |
| Topical PrednisoloneStandard of care topical drop treatment | Drug | Group B Topical Prednisolone |
Primary outcome
Patient Preference
Time frame: Through Month 1 (Day 28 +/- 3 days)
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
6 secondary outcomes
Percentage of Eyes Epithelialized at Day 3
Time frame: Post-Operative Day 3
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative
Time frame: Postoperative Day 4
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)
Time frame: Day 3
SPEED Questionnaire Results at Baseline and Postoperative Day 28
Time frame: Pre-op Visit and Month 1 (Day 28)
Uncorrected Distance Visual Acuity
Time frame: Month 1 and Month 3.
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative
Time frame: Month 1 and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John Berdahl, MD principal investigator
Vance Thompson Vision
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 3 inclusion and 15 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 30 Jul 2024. 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 1 Aug 2023). 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?
Patient Preference (time frame: Through Month 1 (Day 28 +/- 3 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 30 Jul 2024.