Clinical trial: Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision (NCT02194127)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy subjects (volunteers) with age-related impaired twilight and night

          -  Age 50 to 70, men or women

          -  Written informed consent

          -  Full visual acuity (vision ≥ 0.7) according to DIN Standard condition

          -  Refraction ≤ +/-6.0 in the highest main step

          -  Age-related findings in the ophthalmologic examination (anterior chamber and eye
             ground)

          -  Normal intraocular pressure (10-20 mmHg)

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Epilepsy

          -  Abnormal visual acuity or eye ground (e.g. clouding of the lens)

          -  Age related vision problems

          -  Glaucoma and macular degeneration

          -  Disease of the retina

          -  Consumption of anthocyan preparations during the past six months

          -  Opthalmologic pathology: cataract, visus < 0.7, retinal pathology, maculopathy,
             intraocular pressure (> 21 mmHg), known acute or chronic eye disease, use of hard
             contact lenses, eye surgery performed within the last 12 months

          -  Any serious disorder that might interfere with his/her participation in this study and
             the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus,
             anamnestic indications of diabetic microangiopathy or polyneuropathy, renal
             insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension
             > 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino

          -  Any treatment that might interfere with the evaluation of the test drug, in particular
             drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis,
             ethambutol, chlorpromazine or phenothiazine derivatives such as thioridazine,
             periciazine, perphenazine)

          -  Known hypersensitivity to any of the ingredients of the study drug

          -  Drug and alcohol abuse

          -  Pregnancy, lactation, women of childbearing potential who do not use an established
             contraceptive

          -  Participation in another trial within the past 30 days
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 67-year-old man comes to the clinic with slowly worsening vision in both eyes.  He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable.  Ocular examination shows loss of the red reflex and blurry vision.  Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal.

Patient description (patient's own words): I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine.

Does the patient match the trial criteria? Entailment