Dry EyeNCT05737108
Bilberry-containing Capsules for Dry Eye Mitigation
A study testing Bilberry capsule product in people with Dry Eye, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
This study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Bilberry capsule product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 and 65 years
- with Schirmer's test results between 5 - 10 mm or Tear Film Break Up Time less than 10 seconds
- Ocular Surface Disease Index more than 25
Who cannot join
- evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
- diabetes
- hypertension
- or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial on the Efficacy of Bilberry-containing Capsules for Dry Eye Mitigation
This study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 4 bilberry capsules per day for 30 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, and tear compositions. After the 30 days are completed, the participants will be assessed again for the same parameters.
Read the detailed description
This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to group A or group B, and asked to orally intake 4 capsules of either bilberry product or placebo per day.The group A will have bilberry product for 30 days, have a 20-day washout period, and then have placebo for another 30 days. The group B will have placebo for 30 days, have a 20-day washout period, and then have bilberry product for another 30 days. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear composition (Na+, K+, Cl- ions), tear osmolarity, ocular surface impression cytology, and ocular surface disease index (OSDI). The assessments are conducted immediately before the first 30-day and immediately after the second 30-day oral intake period. The parameters are used to compare and evaluate whether the bilberry product can relieve dry eye symptoms.
- Conditions
- Dry Eye
- Being tested
- Bilberry capsule product, Placebo(starch)
- Keywords
- bilberry, anthocyanin, dry eye, eye sore, eye strain
- Medical subject headings
- Dry Eye Syndromes, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilberry capsule productDietary supplement
A specific bilberry capsule product, containing bilberry dried extracts at 23.2 mg and bilberry powder at 3.2 mg will be given to participants for oral intake for 30 days. 30 days of Bilberry capsule product or placebo with crossover to the other.
Placebo(starch)Dietary supplement
30 days of placebo or Bilberry capsule product with crossover to the other.
| Study group | Role | What they receive |
|---|---|---|
| Group A-test samples | Experimental | This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days. Receives: Dietary Supplement: Bilberry capsule product; Dietary Supplement: Placebo(starch) |
| Group A-placebo | Placebo comparator | This group will be given placebo for 30 days and then have a washout period for 20 days. Receives: Dietary Supplement: Bilberry capsule product; Dietary Supplement: Placebo(starch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of Schirmer's Test Value at Day 31
To assess tear secretion volume. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement indicates presence of dry eye disease.
Measured: on baseline and day31
Change From Baseline of Tear Film Breakup Time at Day 31
Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Tear Break-Up Time, the lower the tear film stability. Less than 10 seconds = dry eye disease; lower score indicates worse disease.
Measured: on baseline and day31
Change From Baseline of Ocular Surface Index at Day 31
To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe
Measured: on baseline and day31
Secondary outcomes (4)
Change From Baseline of Tear Contents at Day 31
Determination of changes in osmolality and ion content for test groups of sample or placebo.
Measured: on baseline and day31
Change From Baseline of Ocular Surface Impression Cytology at Day 31
To assess the status of conjunctival goblet cells and epithelium.
Measured: on baseline and day31
Change From Baseline of Ocular Surface Disease Index Score at Day 31
A questionnaire to assess the health status on ocular surface, with higher scores indicating greater disability.
Measured: on baseline and day31
Change From Baseline of Intraocular Pressure at Day 31
To determine the effects of intervention on intraocular pressure.
Measured: on baseline and day31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start24 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention with oral intakes of either test samples or placebo for 30 days, followed by a 20-day period of washout, and then crossover for another 30 days of either test samples or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Glory Kingdom Corporation
- Responsible party
- Sponsor
- Investigators
- David Pei-Cheng Lin, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737108
- Sponsor's protocol ID
- 111-73
- Status last verified
- May 2023
- First submitted
- 18 Nov 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masmali AM, Purslow C, Murphy PJ. The tear ferning test: a simple clinical technique to evaluate the ocular tear film. Clin Exp Optom. 2014 Sep;97(5):399-406. doi: 10.1111/cxo.12160.
PubMed 25138744The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
PubMed 17508116Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.
PubMed 6712760Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975 Nov;59(11):667-9. doi: 10.1136/bjo.59.11.667.
PubMed 1203224Brito-Zeron P, Ramos-Casals M; EULAR-SS task force group. Advances in the understanding and treatment of systemic complications in Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):520-7. doi: 10.1097/BOR.0000000000000096.
PubMed 25050925Sullivan DA, Krenzer KL, Sullivan BD, Tolls DB, Toda I, Dana MR. Does androgen insufficiency cause lacrimal gland inflammation and aqueous tear deficiency? Invest Ophthalmol Vis Sci. 1999 May;40(6):1261-5.
PubMed 10235562Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097.
PubMed 18453777Ozawa Y, Kawashima M, Inoue S, Inagaki E, Suzuki A, Ooe E, Kobayashi S, Tsubota K. Bilberry extract supplementation for preventing eye fatigue in video display terminal workers. J Nutr Health Aging. 2015 May;19(5):548-54. doi: 10.1007/s12603-014-0573-6.
PubMed 25923485Kosehira M, Machida N, Kitaichi N. A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial. Nutrients. 2020 Feb 25;12(3):600. doi: 10.3390/nu12030600.
PubMed 32106548
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on the Efficacy of Bilberry-containing Capsules for Dry Eye Mitigation
- ClinicalTrials.gov ID
- NCT05737108
- Acronym / sponsor ID
- 111-73
- Conditions
- Dry Eye
- Keywords
- bilberry, anthocyanin, dry eye, eye sore, eye strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Glory Kingdom Corporation
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- 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.
This study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 4 bilberry capsules per day for 30 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, and tear compositions. After the 30 days are completed, the participants will be assessed again for the same parameters.
Detailed description
This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to group A or group B, and asked to orally intake 4 capsules of either bilberry product or placebo per day.The group A will have bilberry product for 30 days, have a 20-day washout period, and then have placebo for another 30 days. The group B will have placebo for 30 days, have a 20-day washout period, and then have bilberry product for another 30 days. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear composition (Na+, K+, Cl- ions), tear osmolarity, ocular surface impression cytology, and ocular surface disease index (OSDI). The assessments are conducted immediately before the first 30-day and immediately after the second 30-day oral intake period. The parameters are used to compare and evaluate whether the bilberry product can relieve dry eye symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Intervention with oral intakes of either test samples or placebo for 30 days, followed by a 20-day period of washout, and then crossover for another 30 days of either test samples or placebo.
| Arm | Type | Receives |
|---|---|---|
| Group A-test samples | Experimental | Dietary Supplement: Bilberry capsule product, Dietary Supplement: Placebo(starch)This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days. |
| Group A-placebo | Placebo comparator | Dietary Supplement: Bilberry capsule product, Dietary Supplement: Placebo(starch)This group will be given placebo for 30 days and then have a washout period for 20 days. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 20 and 65 years
- with Schirmer's test results between 5 - 10 mm or Tear Film Break Up Time less than 10 seconds
- Ocular Surface Disease Index more than 25
Key exclusion criteria (4 listed)
- evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
- diabetes
- hypertension
- or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
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 |
|---|---|---|
| Bilberry capsule productA specific bilberry capsule product, containing bilberry dried extracts at 23.2 mg and bilberry powder at 3.2 mg will be given to participants for oral intake for 30 days. 30 days of Bilberry capsule product or placebo with crossover to the other. | Dietary supplement | Group A-placebo, Group A-test samples |
| Placebo(starch)30 days of placebo or Bilberry capsule product with crossover to the other. | Dietary supplement | Group A-placebo, Group A-test samples |
Primary outcome
Change From Baseline of Schirmer's Test Value at Day 31
Time frame: on baseline and day31
To assess tear secretion volume. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement indicates presence of dry eye disease.
Change From Baseline of Tear Film Breakup Time at Day 31
Time frame: on baseline and day31
Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Tear Break-Up Time, the lower the tear film stability. Less than 10 seconds = dry eye disease; lower score indicates worse disease.
Change From Baseline of Ocular Surface Index at Day 31
Time frame: on baseline and day31
To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe
4 secondary outcomes
Change From Baseline of Tear Contents at Day 31
Time frame: on baseline and day31
Change From Baseline of Ocular Surface Impression Cytology at Day 31
Time frame: on baseline and day31
Change From Baseline of Ocular Surface Disease Index Score at Day 31
Time frame: on baseline and day31
Change From Baseline of Intraocular Pressure at Day 31
Time frame: on baseline and day31
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 18 Feb 2025.
- Background: PubMed 25138744Masmali AM, Purslow C, Murphy PJ. The tear ferning test: a simple clinical technique to evaluate the ocular tear film. Clin Exp Optom. 2014 Sep;97(5):399-406. doi: 10.1111/cxo.12160.
- Background: PubMed 17508116The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
- Background: PubMed 6712760Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.
- Background: PubMed 1203224Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975 Nov;59(11):667-9. doi: 10.1136/bjo.59.11.667.
- Background: PubMed 25050925Brito-Zeron P, Ramos-Casals M; EULAR-SS task force group. Advances in the understanding and treatment of systemic complications in Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):520-7. doi: 10.1097/BOR.0000000000000096.
- Background: PubMed 10235562Sullivan DA, Krenzer KL, Sullivan BD, Tolls DB, Toda I, Dana MR. Does androgen insufficiency cause lacrimal gland inflammation and aqueous tear deficiency? Invest Ophthalmol Vis Sci. 1999 May;40(6):1261-5.
- Background: PubMed 18453777Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097.
- Background: PubMed 25923485Ozawa Y, Kawashima M, Inoue S, Inagaki E, Suzuki A, Ooe E, Kobayashi S, Tsubota K. Bilberry extract supplementation for preventing eye fatigue in video display terminal workers. J Nutr Health Aging. 2015 May;19(5):548-54. doi: 10.1007/s12603-014-0573-6.
- Background: PubMed 32106548Kosehira M, Machida N, Kitaichi N. A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial. Nutrients. 2020 Feb 25;12(3):600. doi: 10.3390/nu12030600.
- Individual participant dataSharing planned: No
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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.
David Pei-Cheng Lin, PhD principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilberry capsule product in people with Dry Eye, run by Chung Shan Medical University at 1 site in Taiwan.
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 3 inclusion and 4 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Change From Baseline of Schirmer's Test Value at Day 31 (time frame: on baseline and day31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05737108, which also lists 9 linked publications.
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 18 Feb 2025.