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
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
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
NCT ID
NCT04075227
First Posted
August 28, 2019
Last Updated
September 4, 2019
Sponsor
Wannisa Suphachearabhan
Collaborators
Srinakharinwirot University
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:
PubMed Identifier
23374515
Citation
Mahar PS, Manzar N. Pterygium recurrence related to its size and corneal involvement. J Coll Physicians Surg Pak. 2013 Feb;23(2):120-3.
Results Reference
result
PubMed Identifier
22176664
Citation
Sherwin JC, Hewitt AW, Kearns LS, Griffiths LR, Mackey DA, Coroneo MT. The association between pterygium and conjunctival ultraviolet autofluorescence: the Norfolk Island Eye Study. Acta Ophthalmol. 2013 Jun;91(4):363-70. doi: 10.1111/j.1755-3768.2011.02314.x. Epub 2011 Dec 16.
Results Reference
result
PubMed Identifier
12929992
Citation
Yaisawang S, Piyapattanakorn P. Role of post-operative topical corticosteroids in recurrence rate after pterygium excision with conjunctival autograft. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S215-23.
Results Reference
result
PubMed Identifier
12686302
Citation
Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.
Results Reference
result
PubMed Identifier
17457187
Citation
Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
Results Reference
result
PubMed Identifier
11248822
Citation
Pikkel J, Porges Y, Ophir A. Halting pterygium recurrence by postoperative 5-fluorouracil. Cornea. 2001 Mar;20(2):168-71. doi: 10.1097/00003226-200103000-00011.
Results Reference
result
PubMed Identifier
26060460
Citation
Anguria P, Ntuli S, Carmichael T. Young patient's age determines pterygium recurrence after surgery. Afr Health Sci. 2014 Mar;14(1):72-6. doi: 10.4314/ahs.v14i1.11.
Results Reference
result
PubMed Identifier
27100658
Citation
Han SB, Jeon HS, Kim M, Lee SJ, Yang HK, Hwang JM, Kim KG, Hyon JY, Wee WR. Risk Factors for Recurrence After Pterygium Surgery: An Image Analysis Study. Cornea. 2016 Aug;35(8):1097-103. doi: 10.1097/ICO.0000000000000853.
Results Reference
result
PubMed Identifier
25335376
Citation
Olusanya BA, Ogun OA, Bekibele CO, Ashaye AO, Baiyeroju AM, Fasina O, Ogundipe AO, Ibrahim AO. Risk factors for pterygium recurrence after surgical excision with combined conjunctival autograft (CAG) and intraoperative antimetabolite use. Afr J Med Med Sci. 2014 Mar;43(1):35-40.
Results Reference
result
PubMed Identifier
30538417
Citation
Nuzzi R, Tridico F. How to minimize pterygium recurrence rates: clinical perspectives. Clin Ophthalmol. 2018 Nov 19;12:2347-2362. doi: 10.2147/OPTH.S186543. eCollection 2018.
Results Reference
result
PubMed Identifier
29862166
Citation
Kim KW, Kim JC. Current approaches and future directions in the management of pterygium. Int J Ophthalmol. 2018 May 18;11(5):709-711. doi: 10.18240/ijo.2018.05.01. eCollection 2018.
Results Reference
result
PubMed Identifier
16730066
Citation
Prabhasawat P, Tesavibul N, Leelapatranura K, Phonjan T. Efficacy of subconjunctival 5-fluorouracil and triamcinolone injection in impending recurrent pterygium. Ophthalmology. 2006 Jul;113(7):1102-9. doi: 10.1016/j.ophtha.2006.02.026. Epub 2006 May 26.
Results Reference
result
PubMed Identifier
26211117
Citation
Makornwattana M, Suphachearaphan W. Incidence of steroid induced-ocular hypertension in postoperative pterygium excision. J Med Assoc Thai. 2015 Mar;98 Suppl 2:S151-7.
Results Reference
result
PubMed Identifier
10608921
Citation
Bodor N, Buchwald P. Soft drug design: general principles and recent applications. Med Res Rev. 2000 Jan;20(1):58-101. doi: 10.1002/(sici)1098-1128(200001)20:13.0.co;2-x.
Results Reference
result
PubMed Identifier
29430976
Citation
Comstock TL, Sheppard JD. Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid. Expert Opin Pharmacother. 2018 Mar;19(4):337-353. doi: 10.1080/14656566.2018.1439920. Epub 2018 Mar 7.
Results Reference
result
PubMed Identifier
26984315
Citation
Sheppard JD, Comstock TL, Cavet ME. Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure. Adv Ther. 2016 Apr;33(4):532-52. doi: 10.1007/s12325-016-0315-8. Epub 2016 Mar 17.
Results Reference
result
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Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
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