Primary open angle glaucoma (POAG) Eye Diseases Glaucoma
Conditions
Interventions
This double-blind placebo controlled study has two study arms:
1. The placebo formulation contains lactose, cellulose and magnesium stearate as their sole components
2. The ingredients of the antioxid
Sponsors
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (men or women) suffering from bilateral or unilateral POAG with intraocular pressure (IOP) less than 20 mmHg (treated with local therapy). POAG is defined as primary open angle glaucoma with a cup/disc ratio (CDR) greater than 0.5 and visual field defect of at least the parameters of an automated perimeter (MD, PSD) outside the normal range. 2. Aged between 40 and 60 years 3. IOP controlled only with local anti-glaucomatous medication 4. Visual acuity of at least 0.5 (decimal fractions) 5. Patients have given their written informed consent
Exclusion criteria
Exclusion criteria: 1. Any concomitant medication 2. Vasospastic syndrome (migraine, Raynaud's syndrome) 3. Coronary heart disease 4. Stroke 5. Obesity (body mass index [BMI] greater than 30 kg/m^2) 6. Cardiovascular risk factors: HTN (systolic greater than or equal to 140 mmHg, diastolic greater than or equal to 90 mmHg), known hyperlipidaemia, diabetes mellitus, smokers (greater than 3 cigarettes/day) 7. Severe systemic or ocular disease 8. Autoimmune disease 9. Secondary glaucoma and angle closure glaucoma 10. Exfoliation syndrome 11. Other ocular degenerative disease (cataract, diabetic retinopathy, age-related macular degeneration [ARMD]) 12. History of eye surgery (including laser), trauma 13. Drug, alcohol abuse 14. Known sensitivity to the tested ingredients 15. Supplementation with antioxidants within the previous 3 months 16. Any concomitant nutritional supplementation 17. Involvement in the last 30 days in any other investigational drug study 18. Pregnant and lactating women 19. Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study 20. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period 21. Patients who plan to start a diet or to change their diet during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy variables: 1. Variation of serum total antioxidant status, measured using Total Antioxidant Assay 2. Urine isoprostane values, measured using Prostaglandin Assay The main criteria will be the changes from baseline until 6 months after start of supplementation. The efficacy analyses compare these two criteria in the two groups (supplemented and placebo group). For the analysis blood and urine samples have been drawn from each patient at baseline and after 6 months (180 days). All serum and urine samples have been sent and analysed in a centralised laboratory, with the same method, the same equipment and the same staff for better quality of results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total glutathione status in serum, measured using Glutathione Assay Kit 2. Uric acid status in serum 3. Status of ascorbic acid in serum, determined by individual HPLC 4. Status of tocopherol in serum, determined by individual HPLC 5. Contrast sensitivity 6. Analysis of safety of oral supplementation Serum of blood samples, drawn at baseline and visit 2 (6 months after baseline) of each patient, will be kept frozen for optional analysis of the antibody pattern. Safety was assessed by means of the adverse event report and an ophthalmic examination. In the ophthalmic examination a slit lamp examination was performed, the visual acuity has been assessed, the IOP has been measured using applanation tonometer (always at 8 o'clock in the morning for all patients), a funduscopy was carried out (examination of macula, optic nerve head and cup/disc ratio) and the visual field was analysed. The ophthalmic examination has been performed for the study and the fellow eye. | — |
Countries
Romania
Outcome results
None listed