DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

Refractive Surgery Clinical Trial

— AtLAS  

Official title:

DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281862
• Other study ID #: ATLAS2020
• Status: Recruiting
• Phase: Phase 4
• Start date: January 23, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2020
• Source: Vance Thompson Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractive Surgery

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Vance Thompson Vision ND	W. Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Vance Thompson Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoints	As measured by intraocular pressure increase of 10 mm Hg or greater from baseline.	Through Month 1 (Day 28 +/- 3 days)
Other	Safety Endpoints	As measured by proportion of eyes rescued with additional topical prednisolone treatment or increased frequency of dosing.	Through Month 1 (Day 28 +/- 3 days)
Other	Safety Endpoints	As measured by occurrence of adverse events.	Through Month 1 (Day 28 +/- 3 days)
Primary	Patient Preference	As measured by COMTOL adapted survey.	Through Month 1 (Day 28 +/- 3 days)
Primary	Patient Comfort	As measured by SPEED Questionnaire.	Through Month 1 (Day 28 +/- 3 days)
Secondary	Ocular Surface Health	As measured by corneal staining.	Through Month 1 (Day 28 +/- 3 days)
Secondary	Visual Outcomes	As measured by uncorrected Visual Acuity.	Through Month 1 (Day 28 +/- 3 days)
Secondary	Ocular Pain	As measured by Ocular Pain Assessment.	Through Month 1 (Day 28 +/- 3 days)