ABSTRACT
PURPOSE: 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.
Subject(s)
Carbonic Anhydrase Inhibitors/pharmacology , Intraocular Pressure/drug effects , Sulfonamides/pharmacology , Thiophenes/pharmacology , gamma-Cyclodextrins/chemistry , Carbonic Anhydrase Inhibitors/administration & dosage , Carbonic Anhydrase Inhibitors/adverse effects , Cross-Over Studies , Drug Delivery Systems , Female , Humans , Male , Nanoparticles , Ophthalmic Solutions , Pilot Projects , Prospective Studies , Single-Blind Method , Sulfonamides/administration & dosage , Sulfonamides/adverse effects , Thiophenes/administration & dosage , Thiophenes/adverse effects , Tonometry, Ocular , Visual AcuityABSTRACT
AIM: To examine the age- and gender-specific prevalent and 5-year incident risk of developing exfoliation syndrome (XFS). METHODS AND PARTICIPANTS: In a population-based random sample of citizens 50 years and older, 1045 persons had baseline examination in 1996; 846 of the 958 survivors (88.2%) had a follow-up examination in 2001. Following maximum dilatation of pupils, a diagnosis of exfoliation was established on slit-lamp examination. An extensive questionnaire was administered at baseline and follow-up. Prevalent and incident risk was then calculated using a multivariate analysis. RESULTS: The following variables were found to correlate significantly with prevalence risk of XFS at baseline: age, female gender, increased iris pigmentation, moderate use of alcohol and self-reported asthma. We also found that, compared with those who consumed dietary fibre-rich vegetables, green or yellow vegetables, and fruit less than once a month in their 20s and 40s, those consuming the same food items once or twice every 2 weeks were found to be less likely to have XFS. The same applied to those consuming dietary fibre rich once or twice every 2 weeks in their 40s and 60s. CONCLUSION: Food items that are possibly surrogates for antioxidative effect may correlate with decreased risk of XFS and increased iris pigmentation may correlate with increased risk. Given the large number of comparisons, these findings require validation through additional clinical studies. Increased age and female gender increase the likelihood of XFS.
