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Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

Primary Purpose

Recurrent Pterygium of Eye, Steroid-Induced Glaucoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.2% loteprednol etabonate
0.1% dexamethasone
Sponsored by
Wannisa Suphachearabhan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pterygium of Eye focused on measuring Impending recurrent pterygium, 0.2% loteprednol etabonate, 0.1% dexamethasone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who had pterygium excision with amniotic membrane transplantation and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea

Exclusion Criteria:

  • recurrent pterygium
  • received adjunctive treatment with beta radiation, mitomycin C or 5-fluorouracil
  • glaucoma or intraocular pressure > 21 mmHg
  • history of 5-fluorouracil or chloramphenicol allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    0.2% loteprednol etabonate

    0.1% dexamethasone

    Arm Description

    This group was treated with subconjunctival 5-FU injection and topical 0.2% loteprednol etabonate every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.

    This group was treated with subconjunctival 5-FU injection and topical 0.1% dexamethasone (CD-oph) every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.

    Outcomes

    Primary Outcome Measures

    rate of true recurrent pterygium
    true recurrent pterygium is the fibrovascular tissue that invade into cornea

    Secondary Outcome Measures

    severity score of impending recurrent pterygium
    severity score of impending recurrent pterygium included 3 factors; redness, thickness of fibrovascular tissue, and size of fibrovascular tissue at 3 mm from limbus, which are classified into 3 grades in each factor.
    time to recurrent of pterygium
    time from enrolled participants until they developed true recurrent pterygium
    rate of steroid induced ocular hypertension
    number of participants in each group who had intraocular pressure > 21 mmHg

    Full Information

    First Posted
    August 28, 2019
    Last Updated
    September 4, 2019
    Sponsor
    Wannisa Suphachearabhan
    Collaborators
    Srinakharinwirot University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04075227
    Brief Title
    Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
    Official Title
    A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 16, 2015 (Actual)
    Primary Completion Date
    March 2, 2019 (Actual)
    Study Completion Date
    March 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Wannisa Suphachearabhan
    Collaborators
    Srinakharinwirot University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study was to evaluate the efficacy of topical 0.2% loteprednol etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used in postoperative pterygium excision to prevent the recurrence of pterygium. If 0.2% loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be used postoperatively in pterygium excision patients with the benefit of a low incidence of ocular hypertension or secondary glaucoma.
    Detailed Description
    A prospective randomized control trial was performed from October 2015 to April 2019 at the Department of Ophthalmology, Thammasat Hospital, Thailand and Panyananthaphikkhu Chonprathan Medical Center, Thailand. Subjects Patients who had pterygium excision with amniotic membrane transplantation (AMT) and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea were included. Then the participants were randomized into 2 groups. Both groups received subconjunctival 5-fluorouracil (5-FU) injection 5mg/0.1 mL with 27-gauge needle in the area of fibrovascular tissue, and then the eyes were irrigated with 30 mL of normal saline. 0.2% loteprednol etabonate was prescribed in group 1, and 0.1% dexamethasone (CD-oph) was prescribed in group 2 every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months. 5-FU was repeatedly injected monthly in the presence of marked inflammation and not more than 3 times to prevent complications. All patients were followed-up at 1, 3, 6, and 9 months to assess the impending recurrent pterygium severity score, intraocular pressure, complications, detection of true recurrent pterygium, and time to recurrence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Pterygium of Eye, Steroid-Induced Glaucoma
    Keywords
    Impending recurrent pterygium, 0.2% loteprednol etabonate, 0.1% dexamethasone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants were randomized into 2 groups. Group 1 were treated with subconjunctival 5-FU injection and topical 0.2% loteprednol etabonate while group 2 were treated with subconjunctival 5-FU injection and topical 0.1% dexamethasone (CD-oph: dexamethasone sodium phosphate 1 mg/mL, chloramphenicol 5 mg/mL, tetrahydrozaline hydrochloride 0.25 mg/mL).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0.2% loteprednol etabonate
    Arm Type
    Experimental
    Arm Description
    This group was treated with subconjunctival 5-FU injection and topical 0.2% loteprednol etabonate every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
    Arm Title
    0.1% dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    This group was treated with subconjunctival 5-FU injection and topical 0.1% dexamethasone (CD-oph) every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    0.2% loteprednol etabonate
    Other Intervention Name(s)
    Alrex
    Intervention Description
    Use topical 0.2% loteprednol etabonate eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    0.1% dexamethasone
    Other Intervention Name(s)
    CD-oph
    Intervention Description
    Use topical 0.1% dexamethasone eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
    Primary Outcome Measure Information:
    Title
    rate of true recurrent pterygium
    Description
    true recurrent pterygium is the fibrovascular tissue that invade into cornea
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    severity score of impending recurrent pterygium
    Description
    severity score of impending recurrent pterygium included 3 factors; redness, thickness of fibrovascular tissue, and size of fibrovascular tissue at 3 mm from limbus, which are classified into 3 grades in each factor.
    Time Frame
    6 months
    Title
    time to recurrent of pterygium
    Description
    time from enrolled participants until they developed true recurrent pterygium
    Time Frame
    6 months
    Title
    rate of steroid induced ocular hypertension
    Description
    number of participants in each group who had intraocular pressure > 21 mmHg
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who had pterygium excision with amniotic membrane transplantation and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea Exclusion Criteria: recurrent pterygium received adjunctive treatment with beta radiation, mitomycin C or 5-fluorouracil glaucoma or intraocular pressure > 21 mmHg history of 5-fluorouracil or chloramphenicol allergy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wannisa Suphachearabhan, MD
    Organizational Affiliation
    Srinakharinwirot University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    23374515
    Citation
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    Citation
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    Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

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