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

Steroid-Induced Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075227
• Other study ID #: EC006/60
• Status: Completed
• Phase: Phase 4
• Start date: October 16, 2015
• Est. completion date: March 2, 2019

Study information

• Verified date: September 2019
• Source: Srinakharinwirot University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2, 2019
• Est. primary completion date: March 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pterygium
• Recurrent Pterygium of Eye
• Steroid-Induced Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wannisa Suphachearabhan	Srinakharinwirot University

References & Publications (16)

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. — View Citation

Bodor N, Buchwald P. Soft drug design: general principles and recent applications. Med Res Rev. 2000 Jan;20(1):58-101. Review. — View 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: 1 — View 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. — View Citation

Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. Review. — View 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. — View Citation

Küçükerdönmez C, Akova YA, Altinörs DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. — View 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. doi: 02.2013/JCPSP.120123. — View 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. — View 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. Review. — View 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 Sc — View Citation

Pikkel J, Porges Y, Ophir A. Halting pterygium recurrence by postoperative 5-fluorouracil. Cornea. 2001 Mar;20(2):168-71. — View 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. Epub 2006 May 26. — View 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. Review. — View 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.1755-3768.2011.023 — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of true recurrent pterygium	true recurrent pterygium is the fibrovascular tissue that invade into cornea	6 months
Secondary	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.	6 months
Secondary	time to recurrent of pterygium	time from enrolled participants until they developed true recurrent pterygium	6 months
Secondary	rate of steroid induced ocular hypertension	number of participants in each group who had intraocular pressure > 21 mmHg	6 months