Comparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK

NCT05587231 | Unknown Phase 4 FDA Drug

• 1 other identifier: NMCSD.2021.0059
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Naval Refractive Surgery Center proposes a prospective, single-site, randomized, non-FDA regulated clinical trial with bilateral commercial treatment for for PRK. Subjects will be randomized to receive one of two postoperative steroid regimens: Dextenza (a dexamethasone ophthalmic insert) or standard of care topical Fluorometholone. Subjects will be followed for 3 months after surgery. Investigators will use objective and subjective measures to assess potential differences in postoperative healing and pain. This study will not be FDA-regulated. All study surgeries will be standard of care, with the exception of the addition of the Dextenza insert after the PRK procedure among subjects randomized to the Dextenza group.

Conditions

Steroid Ophthalmic Insert

Keywords

Refractive surgery; PRK (photorefractive keratectomy); Dextenza; Fluorometholone

Outcome Measures

Primary Outcomes (5)

• Self-Reported Postoperative Pain During the First Week Postoperative PRK

  Assessed using a Take Home questionnaire for the first week postop that includes: * Visual analogue scale * Questions about medication utilization (adherence) and frequency

  week 1 post surgery

• Self-Reported Intermediate-Term Postoperative Symptoms

  COMTOL questionnaire given to subjects at their pre and post operative visits

  pre-op, 1 week, 1 month, 3 month

• Epithelial Closure

  Evaluated during post-op visits as yes/no. Evaluation will be done during the slit lamp examination

  1 week, 1 month, 3 months

• Incidence of Haze

  Evaluated during the slit lamp examination and recorded as clinically significant haze Yes/no

  Preop, post op 1 week, 1 month, 3 months

• Refractive Outcomes

  Measured in MRSE, Manifest Refraction and lines of vision loss

  pre-op, 1 week, 1 month, 3 months

Secondary Outcomes (1)

• Return to Duty

  Pre-op, 1 week, 1 month, 3 months

Study Arms (2)

Dextenza 0.4Mg Ophthalmic Insert

EXPERIMENTAL

Dextenza (a dexamethasone ophthalmic insert manufactured by Ocular Therapeutix) will be inserted immediately after PRK surgery to administer a post surgery steroid regimen. No steroid drops will be adminstered.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Topical Fluorometholone

ACTIVE COMPARATOR

Standard of care topical Fluorometholone drops will be used by the subjects after PRK Surgery. There will be a taper as follows: i. 1 drop in each eye QID for 1st week postop. ii. 1 drop in each eye TID for 2nd week postop. iii. 1 drop in each eye BID for 3rd week postop. iv. 1 drop in each eye qD for 4th week postop.

Drug: Topical Fluorometholone

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

The experimental group will have the Dextenza Insert implanted immediately after surgery

Dextenza 0.4Mg Ophthalmic Insert

Topical Fluorometholone DRUG

Steroid drops will be administered by the subject according to the standard of care taper

Topical Fluorometholone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 years of age and older, either active duty or dependents, who are eligible for care;
• Myopia with manifest refractions ranging from 0.00 D to -8.00 D MRSE, with astigmatism ranging from 0.00 to -3.00 D CYL.
• A stable refraction for the past year, as demonstrated by change in Sphere of ≤ 0.50 D and/or change in Cylinder of ≤ 0.50 D in the eyes to be treated;
• A difference between cycloplegic and manifest refractions of
• ≤ 0.75 D MRSE in both eye(s);
• BSCVA at least 20/20 in the treated eyes;
• Discontinue use of contact lenses for at least 4 weeks (for hard lenses) or 2 weeks (for soft lenses) prior to the preoperative examination, and through entire study. The subject shall not be considered a contact lens wearer if they are not wearing hard contact lenses for 4 weeks or soft contact lenses for 2 weeks;
• Central corneal thickness of at least 500 microns in the both eye(s);
• Willing and able to return for scheduled follow-up examinations;
• Able to provide written informed consent and follow study instructions in English.
• Permission of the Commanding Officer for active duty subjects to receive refractive surgery and participate in the study.
• Qualifies for treatment on all study lasers within FDA-approved parameters.

Sponsors & Collaborators

• Navy Medical Center San Diego: lead

Related Publications (5)

• Lee A, Blair HA. Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. Drugs. 2020 Jul;80(11):1101-1108. doi: 10.1007/s40265-020-01344-6.

  PMID: 32588339 BACKGROUND

• Brooks CC, Jabbehdari S, Gupta PK. Dexamethasone 0.4mg Sustained-Release Intracanalicular Insert in the Management of Ocular Inflammation and Pain Following Ophthalmic Surgery: Design, Development and Place in Therapy. Clin Ophthalmol. 2020 Jan 13;14:89-94. doi: 10.2147/OPTH.S238756. eCollection 2020.

  PMID: 32021072 BACKGROUND

• Tyson SL, Campbell P, Biggins J, Driscoll A, Jarrett P, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Punctum and canalicular anatomy for hydrogel-based intracanalicular insert technology. Ther Deliv. 2020 Mar;11(3):173-182. doi: 10.4155/tde-2020-0010. Epub 2020 Mar 16.

  PMID: 32172659 BACKGROUND

• Cheng KJ, Hsieh CM, Nepali K, Liou JP. Ocular Disease Therapeutics: Design and Delivery of Drugs for Diseases of the Eye. J Med Chem. 2020 Oct 8;63(19):10533-10593. doi: 10.1021/acs.jmedchem.9b01033. Epub 2020 Jun 2.

  PMID: 32482069 BACKGROUND

• McLaurin EB, Evans D, Repke CS, Sato MA, Gomes PJ, Reilly E, Blender N, Silva FQ, Vantipalli S, Metzinger JL, Gibson A, Goldstein MH. Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis. Am J Ophthalmol. 2021 Sep;229:288-300. doi: 10.1016/j.ajo.2021.03.017. Epub 2021 Mar 25.

  PMID: 33773984 BACKGROUND

MeSH Terms

Interventions

Calcium Dobesilate; Fluorometholone

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 20, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share