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Completed

NCT Number: NCT04403516

Dextenza in Pterygium Surgery

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)

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York Eye Specialists

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone Intracanalicular Insert, 0.4mg

Drug

To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.

Prednisolone acetate 1%

Drug

To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

Primary outcomes

  1. Patient satisfaction-comfort and convenience

    Time frame: Assessed on Post-Op Day 1

    Assessed by patient reported questionnaire

  2. Patient satisfaction-comfort and convenience

    Time frame: Assessed on Week 1

    Assessed by patient reported questionnaire

  3. Patient satisfaction-comfort and convenience

    Time frame: Assessed on Month 1

    Assessed by patient reported questionnaire

  4. Patient satisfaction-comfort and convenience

    Time frame: Assessed on Month 3

    Assessed by patient reported questionnaire

  5. Patient satisfaction-comfort and convenience

    Time frame: Assessed on Month 6

    Assessed by patient reported questionnaire

Secondary outcomes

  1. To compare the degree of conjunctival hyperemia

    Time frame: Assessed on Week 1

    Assessed by clinical external photography

  2. To compare the degree of conjunctival hyperemia

    Time frame: Assessed on Month 1

    Assessed by clinical external photography

  3. To compare the degree of conjunctival hyperemia

    Time frame: Assessed on Month 2

    Assessed by clinical external photography

  4. To compare the degree of conjunctival hyperemia

    Time frame: Assessed on Month 3

    Assessed by clinical external photography

  5. To compare the degree of conjunctival hyperemia

    Time frame: Assessed on Month 6

    Assessed by clinical external photography

  6. Mean number of days for corneal re-epithelialization

    Time frame: Assessed on Post-Op Day 1

    As evaluated by slit lamp examination

  7. Mean number of days for corneal re-epithelialization

    Time frame: Assessed on Week 1

    As evaluated by slit lamp examination

  8. Mean number of days for corneal re-epithelialization

    Time frame: Assessed on Month 1

    As evaluated by slit lamp examination

  9. Recurrence of pterygium

    Time frame: Assessed at Month 1

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

  10. Recurrence of pterygium

    Time frame: Assessed at Month 2

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

  11. Recurrence of pterygium

    Time frame: Assessed at Month 3

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

  12. Recurrence of pterygium

    Time frame: Assessed at Month 6

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

Sponsors and collaborators

Lead sponsor

Michelle Rhee MD

Other

Collaborators

  • Ocular Therapeutix, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 27, 2020
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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