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NCT Number: NCT04075227

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

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.

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Key information

Conditions

Recurrent Pterygium of Eye Conjunctival Diseases Eye Diseases Pterygium Steroid-Induced Glaucoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

0.2% loteprednol etabonate

Drug

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.

Other names: Alrex

0.1% Dexamethasone

Drug

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.

Other names: CD-oph

Primary outcomes

  1. rate of true recurrent pterygium

    Time frame: 6 months

    true recurrent pterygium is the fibrovascular tissue that invade into cornea

Secondary outcomes

  1. severity score of impending recurrent pterygium

    Time frame: 6 months

    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.

  2. time to recurrent of pterygium

    Time frame: 6 months

    time from enrolled participants until they developed true recurrent pterygium

  3. rate of steroid induced ocular hypertension

    Time frame: 6 months

    number of participants in each group who had intraocular pressure > 21 mmHg

Sponsors and collaborators

Lead sponsor

Wannisa Suphachearabhan

Other

Collaborators

  • Srinakharinwirot University

Registry information

Official study title

A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2019
Registry last updated
Sep 6, 2019

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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