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

NCT04075227 | Completed Phase 4

• 1 other identifier: EC006/60
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Pterygium of Eye; Steroid-Induced Glaucoma

Keywords

Impending recurrent pterygium; 0.2% loteprednol etabonate; 0.1% dexamethasone

Outcome Measures

Primary Outcomes (1)

• rate of true recurrent pterygium

  true recurrent pterygium is the fibrovascular tissue that invade into cornea

  6 months

Secondary Outcomes (3)

• severity score of impending recurrent pterygium

  6 months

• time to recurrent of pterygium

  6 months

• rate of steroid induced ocular hypertension

  6 months

Study Arms (2)

0.2% loteprednol etabonate

EXPERIMENTAL

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

0.1% dexamethasone

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Alrex

0.2% loteprednol etabonate

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.

Also known as: CD-oph

0.1% dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wannisa Suphachearabhan: lead
• Srinakharinwirot University: collaborator

Related Publications (16)

• Mahar PS, Manzar N. Pterygium recurrence related to its size and corneal involvement. J Coll Physicians Surg Pak. 2013 Feb;23(2):120-3.

  PMID: 23374515 RESULT

• 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.

  PMID: 22176664 RESULT

• 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.

  PMID: 12929992 RESULT

• Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.

  PMID: 12686302 RESULT

• 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.

  PMID: 17457187 RESULT

• 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.

  PMID: 11248822 RESULT

• 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.

  PMID: 26060460 RESULT

• 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.

  PMID: 27100658 RESULT

• 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.

  PMID: 25335376 RESULT

• 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.

  PMID: 30538417 RESULT

• 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.

  PMID: 29862166 RESULT

• 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.

  PMID: 16730066 RESULT

• 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.

  PMID: 26211117 RESULT

• 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.

  PMID: 10608921 RESULT

• 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.

  PMID: 29430976 RESULT

• 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.

  PMID: 26984315 RESULT

MeSH Terms

Conditions

Pterygium

Interventions

Loteprednol Etabonate; Dexamethasone

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated

Study Officials

• Wannisa Suphachearabhan, MD

  Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: October 16, 2015
• Primary Completion: March 2, 2019
• Study Completion: March 2, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share