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

Wannisa Suphachearabhan

Status and phase: Completed; Phase 4

Conditions: Recurrent Pterygium of Eye; Steroid-Induced Glaucoma

Treatments: Drug: 0.2% loteprednol etabonate; Drug: 0.1% dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04075227

EC006/60

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

0.2% loteprednol etabonate

Experimental group

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.

Treatment:

Drug: 0.2% loteprednol etabonate

0.1% dexamethasone

Active Comparator group

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.

Treatment:

Drug: 0.1% dexamethasone