Dextenza in Pterygium Surgery

Sponsor
Michelle Rhee MD (Other)
Overall Status
Completed
CT.gov ID
NCT04403516
Collaborator
Ocular Therapeutix, Inc. (Industry)
30
Enrollment
1
Location
2
Arms
10.1
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dexamethasone Intracanalicular Insert, 0.4mg
  • Drug: Prednisolone Acetate 1%
Phase 4

Detailed Description

In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dextenza in Pterygium Surgery
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Aug 5, 2021
Actual Study Completion Date :
Aug 5, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: DEXTENZA Group

Patients with Pterygium DEXTENZA Group

Drug: Dexamethasone Intracanalicular Insert, 0.4mg
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.

Experimental: Topical Prednisolone Acetate 1% Group

Patients with Pterygium Topical Prednisolone Acetate 1% Group

Drug: Prednisolone Acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction-comfort and convenience [Assessed on Post-Op Day 1]

    Assessed by patient reported questionnaire

  2. Patient satisfaction-comfort and convenience [Assessed on Week 1]

    Assessed by patient reported questionnaire

  3. Patient satisfaction-comfort and convenience [Assessed on Month 1]

    Assessed by patient reported questionnaire

  4. Patient satisfaction-comfort and convenience [Assessed on Month 3]

    Assessed by patient reported questionnaire

  5. Patient satisfaction-comfort and convenience [Assessed on Month 6]

    Assessed by patient reported questionnaire

Secondary Outcome Measures

  1. To compare the degree of conjunctival hyperemia [Assessed on Week 1]

    Assessed by clinical external photography

  2. To compare the degree of conjunctival hyperemia [Assessed on Month 1]

    Assessed by clinical external photography

  3. To compare the degree of conjunctival hyperemia [Assessed on Month 2]

    Assessed by clinical external photography

  4. To compare the degree of conjunctival hyperemia [Assessed on Month 3]

    Assessed by clinical external photography

  5. To compare the degree of conjunctival hyperemia [Assessed on Month 6]

    Assessed by clinical external photography

  6. Mean number of days for corneal re-epithelialization [Assessed on Post-Op Day 1]

    As evaluated by slit lamp examination

  7. Mean number of days for corneal re-epithelialization [Assessed on Week 1]

    As evaluated by slit lamp examination

  8. Mean number of days for corneal re-epithelialization [Assessed on Month 1]

    As evaluated by slit lamp examination

  9. Recurrence of pterygium [Assessed at Month 1]

    As measured by yes or no on recurrence; external eye examination

  10. Recurrence of pterygium [Assessed at Month 2]

    As measured by yes or no on recurrence; external eye examination

  11. Recurrence of pterygium [Assessed at Month 3]

    As measured by yes or no on recurrence; external eye examination

  12. Recurrence of pterygium [Assessed at Month 6]

    As measured by yes or no on recurrence; external eye examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• Age of at least 18 years with primary pterygia

Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
  • Glaucoma

  • Ocular hypertension

  • Prior conjunctival surgery

  • Other uncontrolled ocular disease

  • Ocular surgery in either eye within 3 months

  • Use of eye drops other than postoperative medications and artificial tears

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1New York Eye SpecialistsNew YorkNew YorkUnited States10016

Sponsors and Collaborators

  • Michelle Rhee MD
  • Ocular Therapeutix, Inc.

Investigators

  • Principal Investigator: Michelle K Rhee, MD, New York Eye Specialists

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Rhee MD, Principal Investigator, New York Eye Specialists
ClinicalTrials.gov Identifier:
NCT04403516
Other Study ID Numbers:
  • Dextenza in Pterygium Surgery
First Posted:
May 27, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022