DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery
NCT ID: NCT04281862
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2020-01-23
2020-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A
Dextenza
Dextenza 0.4Mg Ophthalmic 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 the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Group B
Topical Prednisolone
Topical Prednisolone
Standard of care topical drop treatment
Interventions
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Dextenza 0.4Mg Ophthalmic 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 the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Topical Prednisolone
Standard of care topical drop treatment
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
18 Years
ALL
Yes
Sponsors
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Vance Thompson Vision
OTHER
Responsible Party
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Locations
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Vance Thompson Vision ND
West Fargo, North Dakota, United States
Countries
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Facility Contacts
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Other Identifiers
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ATLAS2020
Identifier Type: -
Identifier Source: org_study_id
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