Safety and tolerability of naproxen ophthalmic solution in comparison to placebo.

BACKGROUND: Naproxen is a classic non-steroidal anti-inflammatory drug (NSAID) with established analgesic and anti-inflammatory potency. Its action is related to cyclooxygenase inhibition and consequent decrease in prostaglandin concentration in various fluids and tissues. Since prostaglandin release is involved in several ocular alterations, various NSAID eye drops have come into use in the clinical setting during the last decade. SUBJECTS, MATERIAL AND METHODS: A randomized, double-blind, placebo-controlled, three-way crossover design phase I was performed in 12 healthy volunteers to determine both tolerance and safety of a new NSAID ophthalmic solution containing sodium naproxen (0.1% and 0.2%). Both single dose and repeated dose (TID for 6 days) instillation were performed. Evaluation was entirely based upon tolerance criteria. Subjective and objective signs of ocular irritation and subject comfort preference were evaluated. Also medical examination, hematology, blood chemistry and urine analysis were also assessed to evaluate any possible effect of the test drugs and control. RESULTS: Neither ophthalmic tolerance parameters nor vital signs or laboratory parameters were influenced by treatments. A slight hyperemia of the conjunctiva was the only change observed in the eye during the study, whereas the only symptom mentioned was burning. CONCLUSION: It is concluded that both tolerability and safety of 0.1% and 0.2% naproxen solution are acceptable after single and repeated conjunctival administration.

Micropachometric quantification of tear assessment tests.

After reviewing the results of available methods for defining the dry eye with an exact assessment of severity, we found that micropachometry was the most sensitive. The following is a ranking of the other tests according to usefulness: Tear resistance, Schirmer, and BUT. Rose bengal stained eyes were usually decompensated; the meniscus test's primary use was as an "all or nothing" indicator, but recording the widths of extant menisci were unproductive.

[Effectiveness and tolerance of a polyvidon substance in treatment of dry eye syndromes]. / Wirksamkeit und Verträglichkeit eines Polyvidon-Präparates bei Behandlung von Benetzungsstörungen.

BACKGROUND: Insufficient wetting of the ocular surface is very frequent. Artificial tears are commonly used for therapy. The influence on symptoms and tolerability of a product formulated with polyvidon and electrolytes resembling natural tears were investigated. METHOD: Efficacy and local tolerability of a polyvidon (polyvinylpyrrolidon) formulation in the treatment of the "dry-eye" syndrome were tested in an open multicenter study on 586 patients with dry-eye conditions of various etiology. Patients were treated under the conditions of daily usage with the tear substitutes Oculotect fluid or Oculotect fluid sine which are formulations with electrolytes in a composition which resembles natural tears. The duration of treatment was 8 weeks and application frequency was dependent on severity of dry-eye syndrome. The therapeutic effect was evaluated before treatment and after one, four and eight weeks by tear film break-up time (BUT test). Schirmer-I test and by ratings of patient's self assessment of their complaints. Additionally patients general and ophthalmological history was recorded. RESULTS: Before the start of the treatment the BUT test and Schirmer-I test yielded mean values of 9.0 (+/-5.2) sec and 6.2 (+/-3.8) mm respectively. These values increased over the course of the approximately 8-week treatment period to 12.3 (+/-5.6) sec and 10.1 (+/-4.8) mm respectively. Both parameters increased as highly significant (p < or = 0.0001, Wilcoxon-Test). Before treatment patients rated the following complaints as medium strong or strong: sensation of foreign body (66%), burning (69%), sensation of pressure (48%) and/or conjunctival hyperemia (48%). Some 8 weeks later, only 5% (sensation of foreign body), 8% (burning), 5% (sensation of pressure) and 6% (conjunctival hyperemia) of the patients with all examination time points rated these complaints similarly. The efficacy and tolerability were rated by the ophthalmologist on visual analog scales (minimum 0, very poor to a maximum of 100, very good). The average efficacy rating was 72.9 (+/-21.5), Oculotect fluid and Oculotect fluid sine were rated practically identically. The tolerability was rated high at 81.6 (+/-17.6). Reports of undesirable side-effects were given by 15 patients (3%), none of these side-effects were serious. CONCLUSIONS: In patients typically met in ophthalmologists' office, treatment with preserved or unpreserved artificial tear with polyvidone resulted in distinct improvement of their complaints.

[Risks and complications of contact lens use]. / Risiken und Komplikationen des Kontaktlinsentragens.

Hard and soft contact lenses are not always well tolerated--a certain percentage of lens wearers develop eye complications, which may be either mechanical toxic, metabolic, or allergic in nature and are caused by sensitization of the anterior part of the eye by cleaning/disinfecting media or the material of the lens. Inadequate cleaning or disinfection of the lens can also lead to eye injury, as can leaving the lens in the eye for too long. Only thorough patient instruction on the handling and care of the lenses, coupled with regular visits to the ophthalmologist can avoid the development of complications in contact lens wearers.

[Contact lenses--medical indications and problems]. / Kontaktlinsen--medizinische Indikation und Problematik.

Today, hard and soft contact lenses are useful visual aids. In common with any other effective medication, however, they can also produce side effects. They are medically indicated whenever spectacles fail to optimally compensate poor vision. They are not easy to customize, and wearers must be examined by the ophthalmologist more frequently than wearers of eye glasses. Complications are more common with contact lenses than with other visual aids. Nevertheless, modern lens systems do provide optimal correction of impaired sight in any age group. The present paper offers an overview of the limitations and possibilities of treatment with contact lenses, and discusses the medical indications.

Micropachometric investigation of rigid contact lens-induced corneal dystrophies.

We evaluated rigid contact lens associated changes in central corneal thickness using an improved method of pachometry. After altering one lens parameter (e.g., lens diameter or base curve) and keeping all other parameters constant, we evaluated 30 rigid lens patients at 4-hour intervals over 20-hour periods. Using micropachometry we were able to detect changes as small as 10-20 microns in the central cornea region. We found that the degree of corneal swelling from rigid contact lens wear can vary from one area to another. Thinning in one area can result from lens compression, while thickening in an adjacent area can result from lens-induced hypoxia. Using micropachometry for the early detection of corneal changes such as thinning may help to avoid problems associated with long-term lens wear.

[The effective antibacterial spectrum of sulfacetamide]. / Zum antibakteriellen Wirkungsspektrum von Sulfacetamid.

Swabs of the anterior eye segment of 180 eyes (145 patients) taken in the time period between August 1, 1989 until August 30, 1989 were sent to an external, independent microbiological institute in order to verify in-vitro antibacterial properties of marketed sulfacetamide containing drugs. MIC test was performed with isolated pathogenic bacterial strains without knowledge of the underlying diagnosis. It was shown that sulfacetamide is able to inhibit the growth of all isolated strains. Depending on the type of bacteria concentrations of 0.006 up to 6.4% sodium sulfacetamide proved to be effective. Simultaneously, all patients were treated with sulfacetamide containing ointment and/or eye drops 4 times daily for maximum of 14 days. With swabs taken at intervals of 7 and 14 days no bacterial growth was detected.

[Unusual complications after wearing hard and soft contact lenses]. / Seltene Komplikationen nach Tragen harter und weicher Kontaktlinsen.

In a clinical long-term study over a period of 10 years with 3850 patients wearing hard and soft contact lenses, unusual reactions of the cornea and perilimbal conjunctiva have been observed in 3% of all cases. Mainly corneal abrasions, cracks, clouds and mosaics have been observed, which were analyzed as being rare contact lens complications. The causes were lack of proper maintenance of the contact lenses, such as mistakes in cleaning and disinfecting the lenses, mishandling or toxic and allergic reactions due to cleaning and disinfection solutions. Only exact ophthalmological monitoring of the anterior parts of the eye and laboratory tests on the worn lenses permit differentiation between primary eye diseases and contact lens-induced complications.

[Deformation of the central corneal surface following use of hard and soft contact lenses]. / Untersuchungen über die Verformung der zentralen Hornhautvorderfläche nach Tragen harter und weicher Kontaktlinsen.

Use of a computer connected with a slit-lamp-video-camera detected changes in the cornea topography after wearing contact lenses on a daily basis. Also subtle surface changes were observed within the upper portion of the areas measured. These appeared to be spiral-shaped or cloudlike patterns as a result of wearing hard or soft contact lenses respectively. The changes observed appeared to have resulted from movement of the contact lens. However, this device has also been used to determine changes that are similar in early keratokonus. The computer can store data from 1600 sites on the surface; there sites are distributed over a 4-mm diameter area in the central cornea. On command the computer can display an image of the corneal surface. Images from hour 0 and 6 weeks later were compared to determine the topographic differences. The surface patterns observed after 6 weeks of wearing lenses appeared to be involve numerous small depressions.

[Effect of a decade of wearing contact lenses on the physiology and morphology of the eye]. / Der Einfluss des jahrzehntelangen Kontaktlinsentragens auf Physiologie und Morphologie des Auges.

A retrospective study of 230 HEMA eyes and 210 PMMA eyes with a history of regular contact lens wear (no extended wear) for 10 or more years was carried out on subjects with initially normal eyes. One hundred percent of the eyes showed pathologic changes although some of the pathology was of a minor nature. Irregular astigmatism was found in the majority of the PMMA eyes and 44.3% of the HEMA eyes. Pathologic corneal vascularization (greater than 1.5 mm) was found in over 40% of both groups; the HEMA lenses generally caused more and deeper vascularization. These and other observations indicate that when contact lenses, are worn for a decade or longer they may well influence the eye to a greater extent than is widely assumed.

[Fungal growth on soft contact lenses (author's transl)]. / Pilzwachstum auf weichen Kontaktlinsen.

The relevance of fungal contamination of soft contact lenses is demonstrated by own clinical observations in 25 cases. It can be shown by surface-microscopical, histological and mycological analysis, that various fungi can not only grow on the surface of HEMA-lenses, but can also invade the material. The efficacy of chemical disinfectants, as tested against two of the isolated fungi seems to be inferior to that of heat sterilisation. The resulting fundamentally and clinically important consequences, especially concerning permanent wear of hydrophilic contact lenses, are discussed.