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

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ClinicalTrials.gov Identifier: NCT04075227
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Srinakharinwirot University
Information provided by (Responsible Party):
Wannisa Suphachearabhan, Srinakharinwirot University

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.

Condition or disease Intervention/treatment Phase
Recurrent Pterygium of Eye Steroid-Induced Glaucoma Drug: 0.2% loteprednol etabonate Drug: 0.1% dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : October 16, 2015
Actual Primary Completion Date : March 2, 2019
Actual Study Completion Date : March 2, 2019


Arm Intervention/treatment
Experimental: 0.2% loteprednol etabonate
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
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 Name: Alrex

Active Comparator: 0.1% dexamethasone
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 0.1% dexamethasone eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
Other Name: CD-oph




Primary Outcome Measures :
  1. rate of true recurrent pterygium [ Time Frame: 6 months ]
    true recurrent pterygium is the fibrovascular tissue that invade into cornea


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075227


Sponsors and Collaborators
Wannisa Suphachearabhan
Srinakharinwirot University
Investigators
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Principal Investigator: Wannisa Suphachearabhan, MD Srinakharinwirot University
Publications of Results:

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Responsible Party: Wannisa Suphachearabhan, Principal investigator, Srinakharinwirot University
ClinicalTrials.gov Identifier: NCT04075227    
Other Study ID Numbers: EC006/60
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wannisa Suphachearabhan, Srinakharinwirot University:
Impending recurrent pterygium
0.2% loteprednol etabonate
0.1% dexamethasone
Additional relevant MeSH terms:
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Pterygium
Eye Diseases
Conjunctival Diseases
Loteprednol Etabonate
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents