Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Brazil - Ethics Protocol No: 003186/04
Study information
Scientific title
Acronym
The Mitomycin Trial
Study hypothesis
This study aimed to compare the effectiveness of preventing recurrence by using MitoMycin C (MMC) by eyedrop topical administration and subconjunctival administration previous to Conjunctival Autograft Transplantation (CAT) surgery in cases of recurrence, and evaluating epithelial cell proliferation by the Ki 67 antigen as well as the evaluation of cariometry of conjunctive fibroblasts.
Ethics approval
Approved by FAMERP (Faculty of Medicine of São José do Rio Preto - São Paulo State) ethics committee on the 13th November 2004 (research protocol No 003186/04).
Study design
Randomised single-blind placebo-controlled cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Recurrent Pterygium
Intervention
Twenty-nine patients were randomly divided into three groups according to random numbers:
Group one: Nine patients submitted to CAT, using Placebo Eye-Drops (PED) 14 days before the surgery.
Group two: Eleven patients submitted to CAT, and administered subconjunctival injection of 0.1 ml of MMC 0.015% in the head of pterygium 30 days before surgery and PED 14 days before surgery.
Group three: Nine patients submitted to CAT, using MMC eyedrops of 0.02% 14 days before the surgery.
Intervention type
Drug
Phase
Not Specified
Drug names
MitoMycin C (MMC)
Primary outcome measure
1. The recurrence rate after six months follow-up
2. The epithelial cell proliferative activity using as marker the antigen Ki-67
3. Fibroblasts nucleus cariometry to evaluate the area and volume of the nucleus
Secondary outcome measures
To evaluate the safety and efficacy of MMC used topical or subconjunctival route before the surgery treatment of pterygium
Overall trial start date
01/01/2005
Overall trial end date
31/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who presented symptoms of ocular irritation, photophobia and burning pain all concomitant with corneal invasion with more than 3 mm horizontal length, measured starting from the anatomical limbus.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30 patients
Participant exclusion criteria
1. Patients with:
a. keratoconjuntivitis sicca
b. Sjögren disease
c. vernal keratoconjunctivitis
d. acne rosacea
e. neurothrophic keratopathy
f. severe dysfunction of the meibomius glands; patients with meibomius gland dysfunction with clinical indications (symptoms and signs), mild to moderate, were previously treated
2. Patients that use any immunosuppressive drug, through systemic and topical administration
3. Patients aged less than 18 years of age and vulnerable groups
4. Associated glaucoma and the use of ocular hypotensor
Recruitment start date
01/01/2005
Recruitment end date
31/08/2005
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Antonio de Godoi, 3423 ap 41
São José do Rio Preto
15015-100
Brazil
Sponsor information
Organisation
Foundation for the Support of Education and Research (Fundação de Apoio ao Ensino, Pesquisa e Extensão [FAEPE]) (Brazil)
Sponsor details
AV Brigadeiro Faria Lima
5416
São Pedro
São José do Rio Preo
15090-000
Brazil
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Foundation for the Support of Education and Research (Fundação de Apoio ao Ensino, Pesquisa e Extensão [FAEPE]) - FAMERP (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Donnenfeld ED, Perry HD, Fromer S, Doshi S, Solomon R, Biser S, Subconjunctival mitomycin C as adjunctive therapy before pterygium excision., Ophthalmology, 2003, 110, 5, 1012-1016, doi: 10.1016/S0161-6420(03)00091-5.