Dry EyeNCT05481450
Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome
A study testing Blink NutriTears in people with Dry Eye and Dry Eye Syndromes, run by Applied Science & Performance Institute at 3 sites in United States.
Trial summary
This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- Blink NutriTears
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2022to 22 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
- Clinical diagnosis of symptomatic Dry Eye Syndrome confirmed by a licensed optometrist at Baseline by presence of irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort and altered/effected QoL at least in any one of the eyes.
- Subjects shall be in good health and free from any clinically significant disease, other than Dry Eye Syndrome (DES), that might interfere with the study evaluations.
- Subjects must meet the following criteria in at least one eye, as determined by a licensed optometrist:
- Schirmer's Test without anesthesia ≤ 10 mm ii. Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40
- Subjects with any of the following in at least one eye, as determined by a licensed optometrist:
Show all 9Show fewer
- Tear film break up time ≤ 10 seconds ii. Tear Osmolarity ≥ 316 milliosmole /L iii. Fluorescein corneal staining ≥ 1 and < 3.
- Subject willing to provide written consent.
- Subjects shall be willing and able to understand and comply with the requirements of the study, administer the study product as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Who cannot join
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- History of allergy or sensitivity to Lutein, Zeaxanthin, Curcumin or Vitamin D3, related compounds or any component of the formulation.
- Presence of severe dry eye syndrome with complications such as perforated Corneal Ulcer, Uveitis and Glaucoma, in the Investigator's opinion that may interfere with the evaluation of the Subject's Dry Eye Syndrome (DES).
- Current evidence of ocular infections or inflammatory conditions like acute conjunctivitis or other medical condition that, in the Investigator's opinion, would place the Subject at undue risk by participating or compromise the integrity of the study data.
- Subject with poorly controlled diabetes mellitus, rheumatoid arthritis and Systemic Lupus Erythematosus (SLE) which causes Dry Eye Syndrome.
- Subjects with herpetic eye disease.
Show all 18Show fewer
- Subjects with chronic infection of the lacrimal gland.
- Subjects with Laser In Situ Keratomileusis (LASIK).
- Subjects with poorly controlled hypertension (>140/96 mm of Hg).
- Subjects with evidence of malignancy.
- Subjects suffering from major systemic illness necessitating long term drug treatment (Psychological, Neurological, Endocrinal, Cardiovascular disorders, etc.).
- Subjects with concurrent serious Hepatic Dysfunction or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Subjects) or other concurrent severe disease.
- Any ocular trauma or surgery that may affect corneal sensitivity and/or normal tear distribution (e.g., cataract surgery, refractive surgery) within the 6 previous months to study inclusion
- Subjects with inability to swallow soft gel capsules.
- Use of lutein, zeaxanthin, curcumin, or vitamin D3 on prescription for other medical indications or for health-conscious reasons
- Use of steroids or hormone replacement therapy or any other medication that may adversely affect the outcome of the study.
- Subjects on aspirin or anti-coagulant therapy.
- Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
True Eye Experts - Lutz
Lutz, Florida, 33549
Applied Science and Performance Institute
Tampa, Florida, 33607
True Eye Experts - New Tampa
Tampa, Florida, 33647
About this study
Official title: A Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled, Clinical Interventional Study to Evaluate the Efficacy and Safety of Nutritears® in Adult Subjects With Dry Eye Syndrome
This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES). Subjects shall be instructed to consume one capsule of their assigned investigational study product every morning after the breakfast, at the same time every day, for 56 days (8 weeks).
Read the detailed description
Dry eye syndrome (DES) affects a significant population around the world. Tear film moistens and prevents the ocular surface from dust, toxins, pollutants, etc. An imbalance in any of the tear film layers accompanied by glandular dysfunction leads to DES and it affects the ocular surface. The symptoms include discomfort, visual disturbance, inflammation, damage to ocular surface and tear film instability. This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES).
After the informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled in the study. Medical history, including a complete review of all current and past diseases and their respective treatments, will be performed during the screening visit. Physical examination including detailed ocular examination and vital signs (like blood pressure, pulse rate, oxygen saturation and body temperature) will be done during screening. Interviews will be conducted to assess/obtain the medical history, ophthalmic history, systemic disease history, current occupation, exposure to air, presence of allergic problems or concomitant systemic diseases, topical and systemic medications, spectacles/contact lens usage, oral contraceptives, significant history of trauma, chemical burns, drug reactions, history of using any kind of tear substitute, other connective tissue disorder and any history of ocular surgery shall be obtained. Digital screen exposure time from devices like computers, laptops, televisions, tablets, and mobile phones will be recorded.
The following screening tests and procedures shall also be conducted on each potential subject prior to consideration for inclusion into the study:
If the clinical signs and symptoms of DES are present, the following test shall be performed on both the eyes of each subject.
- Schirmer's Test
- Ocular Surface Disease Index (OSDI)
- Tear Film Break-Up Time (TBUT)
- Standard Patient Evaluation of Eye Dryness (SPEED)
- Corneal and Conjunctival Staining
- Tear Osmolarity
- MMP-9 biomarker
If the subject is eligible as per the inclusion/exclusion criteria then, at Randomization Visit, subjects will be randomly (Double-blind) assigned in 1:1 ratio to one of the two (2) treatment groups i.e., Nutritears® or Placebo at Visit 2.
Subjects will be instructed to consume one capsule every morning after the breakfast, at the same time every day, for 56 consecutive days (8 weeks).
Subjects shall complete five scheduled clinic visits as follows:
- Visit 1: Screening Visit (Day -7 to Day -1) • Visit 2: Randomization Visit (Day 1)
- Visit 3: First Follow-Up Visit (Day 14 ± 3 days)
- Visit 4: Second Follow-Up Visit (Day 28 ± 3 days)
- Visit 5: End of Treatment Visit (Day 56 + 3 days) Total study duration for the clinical part shall be a maximum of 66 days which includes the screening period of 7 days, followed by the treatment period of 56 (8 weeks) and an End of study visit at 56 + 3 days.
Safety assessments include monitoring of adverse events (AEs), physical examination, vital signs (heart rate, blood pressure, oxygen saturation, body temperature) and laboratory assessments. Clinical assessments include the Schirmer's Test, Ocular Surface Disease Index (OSDI), Tear Film Break-Up Time (TBUT), Standard Patient Evaluation of Eye Dryness (SPEED) and Corneal and Conjunctival Staining, Tear Osmolarity and MMP-9 biomarker.
A subject diary shall be provided to the subjects to record the Investigational Product administration details, rescue medication (artificial tears) usage, side effects, and concomitant medication details. All subjects shall be instructed to complete the subject diary after each investigational study product administration. Any additional and missed administrations should also be noted in the subject diary. The daily dosing data shall be used to evaluate compliance. Statistical comparisons for therapeutic efficacy shall be made between Nutritears® to the Placebo product.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- Blink NutriTears, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blink NutriTearsDietary supplement
Strength: Lutein/Zeaxanthin - 20/4 mg; Curcuminoids 200 mg; Vitamin D3 600 IU (Total capsule weight ≈670 mg)
PlaceboDietary supplement
Soybean oil capsule (Total capsule weight ≈670 mg)
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Experimental | Consume one capsule every morning after the breakfast at the same time every day for 56 days Receives: Dietary Supplement: Blink NutriTears |
| Placebo | Placebo comparator | Consume one capsule every morning after the breakfast at the same time every day for 56 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's Test (without anesthesia)
Change from Baseline in the length of wetting on a sterile Schirmer's Test strip.
Without previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)
Measured: Baseline, Day 14, Day 28, Day 56
Ocular Surface Disease Index (OSDI) score
Change from Baseline in Ocular Surface Disease Index score. The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.
The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Measured: Baseline, Day 14, Day 28, Day 56
Secondary outcomes (6)
Tear Film Break-Up Time (TBUT)
Change from Baseline in the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. A TBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.
Measured: Baseline, Day 14, Day 28, Day 56
Standard Patient Evaluation of Eye Dryness (SPEED) score
Change from Baseline in the subjects' perception of eye dryness as assessed by Standard Patient Evaluation of Eye Dryness (SPEED) score.
The SPEED questionnaire was designed in order to quickly track the progression of dry eye symptoms over time. This questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms. The symptoms assessed include dryness, grittiness, scratchiness, irritation, burning, watering, soreness, and eye fatigue. The questionnaire further assesses whether these symptoms were not problematic, tolerable, uncomfortable, bothersome, or intolerable
Measured: Baseline, Day 14, Day 28, Day 56
Corneal and Conjunctival Staining
Change from Baseline in Corneal and Conjunctival Staining.
Corneal and conjunctival staining of the ocular surface after instillation of vital dyes was developed to quantify epithelial surface damage in dry eye patients. A modified Oxford score is used to separately score cornea and conjunctiva from 0 to 5 (from 0 = none to 5 = extended areas of confluent stain).
Measured: Baseline, Day 56
Tear Osmolarity
Change from Baseline in Tear Osmolarity
Tear osmolarity refers to the amount of osmotically active particles. Tear osmolarity is abnormal at values greater than 300 milliosmole/L.
Measured: Baseline, Day 56
MMP-9
Change from Baseline in tear inflammatory marker MMP-9.
InflammaDry MMP-9 test kits (QUIDEL, CA, USA) are used for qualitative determination of MMP-9 presence in both eyes. A positive MMP-9 result indicates the presence of MMP9 greater than or equal to 40 ng/ml, and a negative one indicates the presence of MMP-9 less than or equal to 40 ng/ml.
Measured: Baseline, Day 56
Rescue Medication Use
Change from Baseline in rescue medication use
Measured: Baseline, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Aug 2022
- Primary completion15 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Model description
- A prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- True Eye Experts - New Tampa, True Eye Experts - Lutz, True Eye Experts - South Tampa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481450
- Sponsor's protocol ID
- OA051022
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gioia N, Gerson J, Ryan R, Barbour K, Poteet J, Jennings B, Sharp M, Lowery R, Wilson J, Morde A, Rai D, Padigaru M, Periman LM. A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial. Front Ophthalmol (Lausanne). 2024 Apr 24;4:1362113. doi: 10.3389/fopht.2024.1362113. eCollection 2024.
PubMed 38984118
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled, Clinical Interventional Study to Evaluate the Efficacy and Safety of Nutritears® in Adult Subjects With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT05481450
- Acronym / sponsor ID
- OA051022
- Conditions
- Dry Eye, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Collaborators
- True Eye Experts - New Tampa, True Eye Experts - Lutz, True Eye Experts - South Tampa
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 1 Aug 2022 (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 is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES). Subjects shall be instructed to consume one capsule of their assigned investigational study product every morning after the breakfast, at the same time every day, for 56 days (8 weeks).
Detailed description
Dry eye syndrome (DES) affects a significant population around the world. Tear film moistens and prevents the ocular surface from dust, toxins, pollutants, etc. An imbalance in any of the tear film layers accompanied by glandular dysfunction leads to DES and it affects the ocular surface. The symptoms include discomfort, visual disturbance, inflammation, damage to ocular surface and tear film instability. This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES).
After the informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled in the study. Medical history, including a complete review of all current and past diseases and their respective treatments, will be performed during the screening visit. Physical examination including detailed ocular examination and vital signs (like blood pressure, pulse rate, oxygen saturation and body temperature) will be done during screening. Interviews will be conducted to assess/obtain the medical history, ophthalmic history, systemic disease history, current occupation, exposure to air, presence of allergic problems or concomitant systemic diseases, topical and systemic medications, spectacles/contact lens usage, oral contraceptives, significant history of trauma, chemical burns, drug reactions, history of using any kind of tear substitute, other connective tissue disorder and any history of ocular surgery shall be obtained. Digital screen exposure time from devices like computers, laptops, televisions, tablets, and mobile phones will be recorded.
The following screening tests and procedures shall also be conducted on each potential subject prior to consideration for inclusion into the study:
If the clinical signs and symptoms of DES are present, the following test shall be performed on both the eyes of each subject.
- Schirmer's Test
- Ocular Surface Disease Index (OSDI)
- Tear Film Break-Up Time (TBUT)
- Standard Patient Evaluation of Eye Dryness (SPEED)
- Corneal and Conjunctival Staining
- Tear Osmolarity
- MMP-9 biomarker
If the subject is eligible as per the inclusion/exclusion criteria then, at Randomization Visit, subjects will be randomly (Double-blind) assigned in 1:1 ratio to one of the two (2) treatment groups i.e., Nutritears® or Placebo at Visit 2.
Subjects will be instructed to consume one capsule every morning after the breakfast, at the same time every day, for 56 consecutive days (8 weeks).
Subjects shall complete five scheduled clinic visits as follows:
- Visit 1: Screening Visit (Day -7 to Day -1) • Visit 2: Randomization Visit (Day 1)
- Visit 3: First Follow-Up Visit (Day 14 ± 3 days)
- Visit 4: Second Follow-Up Visit (Day 28 ± 3 days)
- Visit 5: End of Treatment Visit (Day 56 + 3 days) Total study duration for the clinical part shall be a maximum of 66 days which includes the screening period of 7 days, followed by the treatment period of 56 (8 weeks) and an End of study visit at 56 + 3 days.
Safety assessments include monitoring of adverse events (AEs), physical examination, vital signs (heart rate, blood pressure, oxygen saturation, body temperature) and laboratory assessments. Clinical assessments include the Schirmer's Test, Ocular Surface Disease Index (OSDI), Tear Film Break-Up Time (TBUT), Standard Patient Evaluation of Eye Dryness (SPEED) and Corneal and Conjunctival Staining, Tear Osmolarity and MMP-9 biomarker.
A subject diary shall be provided to the subjects to record the Investigational Product administration details, rescue medication (artificial tears) usage, side effects, and concomitant medication details. All subjects shall be instructed to complete the subject diary after each investigational study product administration. Any additional and missed administrations should also be noted in the subject diary. The daily dosing data shall be used to evaluate compliance. Statistical comparisons for therapeutic efficacy shall be made between Nutritears® to the Placebo product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: Blink NutriTearsConsume one capsule every morning after the breakfast at the same time every day for 56 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboConsume one capsule every morning after the breakfast at the same time every day for 56 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
- Clinical diagnosis of symptomatic Dry Eye Syndrome confirmed by a licensed optometrist at Baseline by presence of irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort and altered/effected QoL at least in any one of the eyes.
- Subjects shall be in good health and free from any clinically significant disease, other than Dry Eye Syndrome (DES), that might interfere with the study evaluations.
- Subjects must meet the following criteria in at least one eye, as determined by a licensed optometrist:
- Subjects with any of the following in at least one eye, as determined by a licensed optometrist:
Key exclusion criteria (18 listed)
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- History of allergy or sensitivity to Lutein, Zeaxanthin, Curcumin or Vitamin D3, related compounds or any component of the formulation.
- Presence of severe dry eye syndrome with complications such as perforated Corneal Ulcer, Uveitis and Glaucoma, in the Investigator's opinion that may interfere with the evaluation of the Subject's Dry Eye Syndrome (DES).
- Current evidence of ocular infections or inflammatory conditions like acute conjunctivitis or other medical condition that, in the Investigator's opinion, would place the Subject at undue risk by participating or compromise the integrity of the study data.
- Subject with poorly controlled diabetes mellitus, rheumatoid arthritis and Systemic Lupus Erythematosus (SLE) which causes Dry Eye Syndrome.
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 |
|---|---|---|
| Blink NutriTearsStrength: Lutein/Zeaxanthin - 20/4 mg; Curcuminoids 200 mg; Vitamin D3 600 IU (Total capsule weight ≈670 mg) | Dietary supplement | Dietary supplement |
| PlaceboSoybean oil capsule (Total capsule weight ≈670 mg) | Dietary supplement | Placebo |
Primary outcome
Schirmer's Test (without anesthesia)
Time frame: Baseline, Day 14, Day 28, Day 56
Change from Baseline in the length of wetting on a sterile Schirmer's Test strip. Without previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)
Ocular Surface Disease Index (OSDI) score
Time frame: Baseline, Day 14, Day 28, Day 56
Change from Baseline in Ocular Surface Disease Index score. The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
6 secondary outcomes
Tear Film Break-Up Time (TBUT)
Time frame: Baseline, Day 14, Day 28, Day 56
Standard Patient Evaluation of Eye Dryness (SPEED) score
Time frame: Baseline, Day 14, Day 28, Day 56
Corneal and Conjunctival Staining
Time frame: Baseline, Day 56
Tear Osmolarity
Time frame: Baseline, Day 56
MMP-9
Time frame: Baseline, Day 56
Rescue Medication Use
Time frame: Baseline, Day 56
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 4 Jun 2026.
- Derived from this study: PubMed 38984118Gioia N, Gerson J, Ryan R, Barbour K, Poteet J, Jennings B, Sharp M, Lowery R, Wilson J, Morde A, Rai D, Padigaru M, Periman LM. A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial. Front Ophthalmol (Lausanne). 2024 Apr 24;4:1362113. doi: 10.3389/fopht.2024.1362113. eCollection 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blink NutriTears in people with Dry Eye and Dry Eye Syndromes, run by Applied Science & Performance Institute at 3 sites in United States.
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 9 inclusion and 18 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Schirmer's Test (without anesthesia) (time frame: Baseline, Day 14, Day 28, Day 56). The study lists 2 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 NCT05481450, which also lists 1 linked publication.
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 4 Jun 2026.