[Tolerance of a new calcium-alginate-insert for controlled medication therapy of the eye]

Ophthalmologe. 2004 May;101(5):496-9. doi: 10.1007/s00347-003-0901-4.
[Article in German]

Abstract

Purpose: For an effective pharmaceutical treatment it is necessary in some cases to maintain a constant drug level over a certain period. This cannot be achieved by conventional eye drop application. Therefore, a new insert basically consisting of alginates with a different hydroxyethylcellulose (HEC) content was developed. The aim of this study was to evaluate the tolerance of these inserts applied to the conjunctival cul de sac.

Methods: 24 healthy volunteers received the insert containing different concentrations of hydroxyethylcellulose (0%, 5%, 30%) for 1 up to 5 days. The eyes have been examined several times (including visual acuity, ocular surface morphology, break-up-time, Schirmer-Tear-Test). Subjective parameters were pain sensations or daily life disturbance.

Results: After an initial conjunctival hyperemia and a mild foreign body sensation, the insert was well tolerated. No variations concerning the tolerance between the different concentrations of hydroxyethylcellulose were observed.

Conclusion: This study showed good tolerance of the new calcium-alginate-insert applied to the ocular surface for controlled drug release.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial

MeSH terms

  • Alginates*
  • Biocompatible Materials / chemistry
  • Drug Carriers / administration & dosage
  • Drug Carriers / adverse effects*
  • Drug Carriers / chemistry
  • Drug Delivery Systems / adverse effects*
  • Drug Delivery Systems / methods*
  • Drug Implants / administration & dosage
  • Drug Implants / adverse effects*
  • Drug Implants / chemistry
  • Eye Diseases / diagnosis
  • Eye Diseases / etiology*
  • Foreign-Body Reaction / diagnosis
  • Foreign-Body Reaction / etiology*
  • Glucuronic Acid*
  • Hexuronic Acids*
  • Humans
  • Materials Testing
  • Ophthalmic Solutions / administration & dosage*

Substances

  • Alginates
  • Biocompatible Materials
  • Drug Carriers
  • Drug Implants
  • Hexuronic Acids
  • Ophthalmic Solutions
  • Glucuronic Acid