Evaluation of Tranilast to Treat Pterygium Before Excision

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Recurrent or secondary pterygium often has often a growing fibrovascular tissue more exuberant than the primary. Histological findings differ from the primary, since the typical changes in the degenerate connective tissue are absent. The strong immunoreactivity and release of basic fibroblast growth (b-FGF) in cultured fibroblasts of recurrent pterygia suggest that fibroblasts may play an important role in pterygium recurrence. Tranilast used is an antiallergic drug that has an inhibitory effect on the release of chemical transmitters, such as histamine and leukotrienes from mast cells as well as a suppressive effect on vascular permeability.This drug also reduces TGF-β1 production and collagen synthesis in various cells. Tranilast might reduce pterygium recurrence by suppressing TGF-β1 synthesis in conjunctival fibroblast after pterygium surgery. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. Tranilast might be an alternative of mitomycin use, and also less toxic. This study aim to compare the effectiveness of preventing recurrence by using tranilast by topical subconjunctival administration previous to conjunctival autograft transplantation surgery in cases of primary pterygium, and will be perform clinical evaluation and TGF-beta-1 immunohistochemical detection by the anti-TGF-beta 1 antibody as well as fibroblast culture.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gildasio Castello de Almeida Junior
• Collaborator: Hospital de Base
• Treatments: Fibrin Tissue Adhesive; Tranilast

Criteria

Inclusion Criteria:

• Primary pterygium

Exclusion Criteria:

• Keratoconjunctivitis sicca

• Sjögren disease

• Vernal keratoconjunctivitis

• Acne rosacea

• Neurotrophic keratopathy

• Severe dysfunction of the meibomius glands

• Use of any immunosuppressive drug, through systemic and topical route

• Aged under 18 years of age and vulnerable groups

• Glaucoma and use of ocular hipotensor