HealthyPhase 2NCT02194127
Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision
A Phase 2 study testing Anthocyan capsules in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Anthocyan capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Jun 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: Efficacy and Tolerability of a Treatment Over 28 Days With a Bilberry Extract Standardised to a Content of 25% Anthocyanidines in Volunteers With Impaired Twilight and Night Vision
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.
- Conditions
- Healthy
- Being tested
- Anthocyan capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyan capsulesDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Anthocyan capsules | Experimental | capsules containing 160 mg standardised bilberry extract (25% anthocyanidines) Receives: Drug: Anthocyan capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the maximum velocity of dilatation of the pupil
Measured: day 29
Secondary outcomes (16)
Measurement of the maximum velocity of dilatation of the pupil
Measured: Days 1 and 8
Measurement of the initial pupil diameter
Measured: days 1, 8 and 29
Measurement of the latency time
Measured: Days 1, 8 and 29
Measurement of the absolute and relative constriction amplitude
Measured: Days 1, 8 and 29
Measurement of maximum velocity of contraction
Measured: Days 1, 8 and 29
Measurement of velocity of contraction 2
Measured: Days 1, 8 and 29
Measurement of initial minimal contrast level
Determined with Gecko Contrast card
Measured: Days 1, 8 and 29
Time to regain contrast vision at one level above the initial minimal contrast
Determined with Gecko Contrast card
Measured: days 1, 8 and 29
Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare
determined with Mesoptometer II
Measured: Days 1, 8 and 29
Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare
determined with Mesoptometer II
Measured: Days 1, 8 and 29
Recovery time after dazzling
Measured: Days 1, 8 and 29
Change of potential (µVolt) in retina due to photo activation
Measured with Standard Electroretinography (ERG)
Measured: Baseline, days 1, 8 and 29
Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire
Measured: Pre-dose and days 1, 8 and 29
Assessment of clinical global impression on a 5-point rating scale
Measured: Day 29
Number of patients with adverse events
Measured: up to day 29
Number of patients with significant changes in laboratory parameters
Measured: Baseline and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startNov 1998
- Primary completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194127
- Sponsor's protocol ID
- 1147.2
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Treatment Over 28 Days With a Bilberry Extract Standardised to a Content of 25% Anthocyanidines in Volunteers With Impaired Twilight and Night Vision
- ClinicalTrials.gov ID
- NCT02194127
- Acronym / sponsor ID
- 1147.2
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Jun 1999 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyan capsules | Experimental | Drug: Anthocyan capsulescapsules containing 160 mg standardised bilberry extract (25% anthocyanidines) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- Diabetes mellitus
- Epilepsy
- Abnormal visual acuity or eye ground (e.g. clouding of the lens)
- Age related vision problems
- Glaucoma and macular degeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthocyan capsules | Drug | Anthocyan capsules |
| Placebo | Drug | Placebo |
Primary outcome
Measurement of the maximum velocity of dilatation of the pupil
Time frame: day 29
16 secondary outcomes
Measurement of the maximum velocity of dilatation of the pupil
Time frame: Days 1 and 8
Measurement of the initial pupil diameter
Time frame: days 1, 8 and 29
Measurement of the latency time
Time frame: Days 1, 8 and 29
Measurement of the absolute and relative constriction amplitude
Time frame: Days 1, 8 and 29
Measurement of maximum velocity of contraction
Time frame: Days 1, 8 and 29
Measurement of velocity of contraction 2
Time frame: Days 1, 8 and 29
Measurement of initial minimal contrast level
Time frame: Days 1, 8 and 29
Time to regain contrast vision at one level above the initial minimal contrast
Time frame: days 1, 8 and 29
Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare
Time frame: Days 1, 8 and 29
Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare
Time frame: Days 1, 8 and 29
Recovery time after dazzling
Time frame: Days 1, 8 and 29
Change of potential (µVolt) in retina due to photo activation
Time frame: Baseline, days 1, 8 and 29
Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire
Time frame: Pre-dose and days 1, 8 and 29
Assessment of clinical global impression on a 5-point rating scale
Time frame: Day 29
Number of patients with adverse events
Time frame: up to day 29
Number of patients with significant changes in laboratory parameters
Time frame: Baseline and day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anthocyan capsules in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the maximum velocity of dilatation of the pupil (time frame: day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.