title: γ-Cyclodextrin nanoparticle eye drops with dorzolamide: effect on intraocular pressure in man.
abstract: OBJECTIVE
  To test a new drug delivery platform with dorzolamide γ-cyclodextrin (γCD) nanoparticle eye drops for intraocular pressure (IOP) control and safety and compare with Trusopt.(®)
  
  
  METHODS
  Self-aggregating γCD nanoparticle eye drops containing 3% dorzolamide were given once a day (QD) and compared with Trusopt given three times a day (TID) in a prospective randomized single masked crossover trial over 24 h. Seventeen subjects with IOP over 18 mmHg were recruited. IOP was measured with an Icare Tonometer Pro.(®)
  
  
  RESULTS
  There was no statistically significant difference in the IOP lowering effect of dorzolamide nanoparticle eye drops QD and Trusopt TID. At peak (4 h), the IOP reduction from baseline was 3.8±2.6 mmHg (18%, P<0.05) in the nanoparticle eye drop group and 3.1±3.7 mmHg in the Trusopt group (14%, P<0.05, P=0.97 between groups). At trough (24 h), the IOP reduction was 1.4±2.8 mmHg (6%, P>0.05) in nanoparticle eye drop group and 1.5±2.0 mmHg (7%, P>0.05) in the Trusopt group (P=0.23 between groups). Burning sensation measured on the visual analogue scale (1-100) was less from the nanoparticle eye drops (12±15) than from the Trusopt (37±30), (P=0.0038). Visual acuity and conjunctival hyperemia did not differ between the two groups.
  
  
  CONCLUSIONS
  Dorzolamide cyclodextrin nanoparticle eye drops QD lower IOP and the effect seems comparable to Trusopt given TID. The nanoparticle eye drops are well tolerated and seem to have a better safety profile than Trusopt.
authors.affiliation: 1 Department of Ophthalmology, Landspitali University Hospital , Reykjavik, Iceland .
authors.forename: Birna S
authors.initials: BS
authors.lastname: Gudmundsdottir
authors.forename: Dyrleif
authors.initials: D
authors.lastname: Petursdottir
authors.forename: Gudrun M
authors.initials: GM
authors.lastname: Asgrimsdottir
authors.forename: Maria S
authors.initials: MS
authors.lastname: Gottfredsdottir
authors.forename: Sveinn H
authors.initials: SH
authors.lastname: Hardarson
authors.forename: Gauti
authors.initials: G
authors.lastname: Jóhannesson
authors.forename: Sergey V
authors.initials: SV
authors.lastname: Kurkov
authors.forename: Phatsawee
authors.initials: P
authors.lastname: Jansook
authors.forename: Thorsteinn
authors.initials: T
authors.lastname: Loftsson
authors.forename: Einar
authors.initials: E
authors.lastname: Stefánsson
mesh_terms: D002257:Carbonic Anhydrase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D018592:Cross-Over Studies; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D053758:Nanoparticles; D009883:Ophthalmic Solutions; D010865:Pilot Projects; D011446:Prospective Studies; D016037:Single-Blind Method; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D014065:Tonometry, Ocular; D014792:Visual Acuity; D047408:gamma-Cyclodextrins / Q000737:chemistry*
chemical_list: D002257:Carbonic Anhydrase Inhibitors; D009883:Ophthalmic Solutions; D013449:Sulfonamides; D013876:Thiophenes; D047408:gamma-Cyclodextrins; C062765:dorzolamide; C023792:gamma-cyclodextrin