Clinical trial NCT04281862: DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery
Official title: DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Refractive Surgery
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Patient Preference
timeFrame: Through Month 1 (Day 28 +/- 3 days)
measure: Patient Comfort
timeFrame: Through Month 1 (Day 28 +/- 3 days)
Secondary outcomes:
measure: Ocular Surface Health
timeFrame: Through Month 1 (Day 28 +/- 3 days)
measure: Visual Outcomes
timeFrame: Through Month 1 (Day 28 +/- 3 days)
measure: Ocular Pain
timeFrame: Through Month 1 (Day 28 +/- 3 days)
Other outcomes:
measure: Safety Endpoints
timeFrame: Through Month 1 (Day 28 +/- 3 days)
measure: Safety Endpoints
timeFrame: Through Month 1 (Day 28 +/- 3 days)
measure: Safety Endpoints
timeFrame: Through Month 1 (Day 28 +/- 3 days)
Locations:
city: W. Fargo
country: United States
facility: Vance Thompson Vision ND
state: North Dakota
Study officials:
References: