A Phase 4 interventional study of 0.2% loteprednol etabonate and 0.1% dexamethasone in Recurrent Pterygium of Eye and Steroid-Induced Glaucoma, sponsored by Wannisa Suphachearabhan. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Wannisa Suphachearabhan · Phase 4, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 108 is above the median of 60 across 93 interventional studies indexed under Pterygium.
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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.
Drug: 0.2% loteprednol etabonate
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.
Drug: 0.1% dexamethasone
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.
Also known as: Alrex
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.
Also known as: CD-oph
rate of true recurrent pterygium
true recurrent pterygium is the fibrovascular tissue that invade into cornea
Time frame: 6 months
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 frame: 6 months
time to recurrent of pterygium
time from enrolled participants until they developed true recurrent pterygium
Time frame: 6 months
rate of steroid induced ocular hypertension
number of participants in each group who had intraocular pressure \> 21 mmHg
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Loteprednol Etabonate