rss
Br J Ophthalmol 2006;90:574-578 doi:10.1136/bjo.2005.080424
  • Clinical science
    • Extended reports

Comparison of a non-preserved 0.1% T-Gel eye gel (single dose unit) with a preserved 0.1% T-Gel eye gel (multidose) in ocular hypertension and glaucomatous patients

  1. D L Easty1,
  2. G Nemeth-Wasmer2,
  3. J-P Vounatsos3,
  4. B Girard4,
  5. N Besnainou5,
  6. P Pouliquen6,
  7. L Delval6,
  8. J-F Rouland7
  1. 1Department of Ophthalmology, Bristol Eye Hospital, Lower Maudlin Street, Bristol BS1 2LX, UK
  2. 25 place du 2 Février, 68000 Colmar, France
  3. 330 cours de l’Intendance, 33000 Bordeaux, France
  4. 441 rue de Liège, 75008 Paris, France
  5. 59 avenue de la République, 94700 Maisons Alfort, France
  6. 6Laboratoires THEA, 12 rue Louis-Blériot, ZI du Brézet, 63017 Clermont-Ferrand Cedex 2, France
  7. 7Hôpital Huriez, Aile Ouest, Service d’Ophtalmologie, Place de Verdun, 59000 Lille, France
  1. Correspondence to: Professor David L Easty Department of Ophthalmology, Bristol Eye Hospital, Lower Maudlin Street, Bristol BS1 2LX, UK; david.easty{at}bristol.ac.uk
  • Accepted 3 December 2005

Abstract

Aim: This comparative, open design, phase III study was to assess the non-inferiority of the non-preserved T-Gel 0.1% single dose unit (SDU) versus its preserved multidose (MD) reference.

Methods: 175 patients with bilateral POAG or OHT were randomised: 87 patients were to receive one drop daily of T-Gel 0.1% MD and 88 patients were to receive one drop daily of T-Gel 0.1% SDU, for a treatment period of 12 weeks. The primary efficacy variable was the change in intraocular pressure (IOP) in the worse eye between the baseline and the last assessment. Subjective and objective ocular signs as well as adverse events were recorded for safety. Global tolerance was assessed by the investigator and by the patient.

Results: The mean percentage reduction from baseline IOP was 24% for both treatments groups, which was consistent with previous studies. The safety results were comparable in both treatment groups. Because of gel formulation, mild short lasting episodes of blurred vision occurred for about 20% of patients. The global tolerance assessment reported that both treatments were well tolerated.

Conclusion: The overall study results demonstrated that T-Gel 0.1% SDU is not inferior to T-Gel 0.1% MD.

Footnotes

    This Article

    1. Abstract
    2. Full text
    3. PDF

    Responses

    1. Submit a response
    2. No responses published

    Social bookmarking

    Register for free content


    Free sample
     This recent issue is free to all users to allow everyone the opportunity to see the full scope and typical content of BJO.
    View free sample issue >>

    Free archive
    The full back archive is now available for BJO. Institutional subscribers may access the entire archive as part of their subscription. Personal subscribers will also have access to all content when logged in. Non-subscribers who register have free access to all articles published before 2006, back to volume 1 issue 1.
    Register to access the free archive >>

    Don't forget to sign up for content alerts so you keep up to date with all the articles as they are published.