Dry EyePhase 4NCT04163328
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
A Phase 4 study testing HydroEye® in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Contact Lens Complication
- What is being tested?
- HydroEye®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2022to 21 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Provide informed consent and authorization to disclose protected health information
- Willing to follow study protocol
- Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
- Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5 days per week for the past 30 days
- Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses
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- Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12)
- Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report
- Clinical assessment that contact lens material, fit, prescription, and care system are not reasons for contact lens discomfort
- Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2
- Willing to discontinue use of any current dry eye treatment (including use of commercial hygiene masks, and except for artificial tears) for 4 weeks before randomization and during the course of the 6-month study.
Who cannot join
- Meibomian gland dropout ≥75% in either eyelid
- Any changes to the contact lens material, fit, prescription, or care system in the 30 days preceding enrollment or anticipates needing to make changes during the course of the study
- Any systemic disease known to be associated with dry eye
- Any significant ocular surface abnormality that could be associated with ocular surface discomfort, such as ectropion, entropion, trichiasis, infection, severe allergic conjunctivitis, severe eyelid inflammation, etc.
- Any overnight wear of contact lenses or use of daily disposable contact lenses
- Any previous corneal surgery, including all types of corneorefractive surgery
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- Have temporary and/or permanent punctal plugs inserted
- Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days
- Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week).
- Use of anticoagulant therapy or regular, daily use of aspirin, NSAIDs, or steroid medications within the past 30 days, or a history of easy bruising
- Allergy or intolerance to fish or any ingredients contained in the active or placebo formulas [See appendix or ingredient list]
- Participation in a clinical trial in the past 30 days
- Current pregnancy or breast feeding as indicated by self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry eye patients who were not contact lens wearers and found that symptoms and corneal smoothness improved in response to HydroEye® supplementation. To date, HydroEye® has not been assessed in patients with contact lens discomfort; therefore, the purpose of this clinical trial is to determine the efficacy of HydroEye® as a treatment for contact lens discomfort.
- Conditions
- Dry Eye, Contact Lens Complication
- Being tested
- HydroEye®
- Keywords
- HydroEye®, Contact Lens Discomfort, Dry Eye, Supplement
- 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.
HydroEye®Drug
This is an omega-3 fatty acids supplement.
| Study group | Role | What they receive |
|---|---|---|
| HydroEye® | Experimental | Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). Receives: Drug: HydroEye® |
| Placebo | Placebo comparator | Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). Receives: Drug: HydroEye® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.
Measured: 6 months
Secondary outcomes (7)
Average of Tear LTB4 Levels in Picograms Per Milliliter
If there is an adequate number of tear samples collected, LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation. Pooled tears may be needed.
Measured: Baseline, 6 months
Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score
The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.
Measured: 6 months
Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score
NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic. The survey is used to assess serious and chronic pain; therefore the number of subjects with non-zero NPSI values was expected to be minimal, and change to non-zero values was measured in treatment and placebo arms.
Measured: 6 months
Average Tear Breakup Time in Seconds
This is a measure of tear stability with higher values being better (seconds).
Measured: 6 months
Average Schirmer I Test in mm
This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Measured: 6 months
Average Corneal Staining Score
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15) with higher scores being worse.
Measured: 6 months
Average Conjunctival Staining Score
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start16 Sep 2022
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Why it stopped: COVID disruptions to recruitment and study completion, unforeseen staffing and other issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Nichols, University of Alabama at Birmingham
- Investigators
- Kelly K Nichols, OD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163328
- Sponsor's protocol ID
- 000526521
- Status last verified
- Mar 2025
- First submitted
- 12 Nov 2019
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
- ClinicalTrials.gov ID
- NCT04163328
- Acronym / sponsor ID
- 000526521
- Conditions
- Dry Eye, Contact Lens Complication
- Keywords
- HydroEye®, Contact Lens Discomfort, Dry Eye, Supplement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID disruptions to recruitment and study completion, unforeseen staffing and other issues
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry eye patients who were not contact lens wearers and found that symptoms and corneal smoothness improved in response to HydroEye® supplementation. To date, HydroEye® has not been assessed in patients with contact lens discomfort; therefore, the purpose of this clinical trial is to determine the efficacy of HydroEye® as a treatment for contact lens discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HydroEye® | Experimental | Drug: HydroEye®Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). |
| Placebo | Placebo comparator | Drug: HydroEye®Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years
- Provide informed consent and authorization to disclose protected health information
- Willing to follow study protocol
- Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
- Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5 days per week for the past 30 days
Key exclusion criteria (13 listed)
- Meibomian gland dropout ≥75% in either eyelid
- Any changes to the contact lens material, fit, prescription, or care system in the 30 days preceding enrollment or anticipates needing to make changes during the course of the study
- Any systemic disease known to be associated with dry eye
- Any significant ocular surface abnormality that could be associated with ocular surface discomfort, such as ectropion, entropion, trichiasis, infection, severe allergic conjunctivitis, severe eyelid inflammation, etc.
- Any overnight wear of contact lenses or use of daily disposable contact lenses
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 |
|---|---|---|
| HydroEye®This is an omega-3 fatty acids supplement. | Drug | HydroEye®, Placebo |
Primary outcome
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Time frame: 6 months
The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.
7 secondary outcomes
Average of Tear LTB4 Levels in Picograms Per Milliliter
Time frame: Baseline, 6 months
Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score
Time frame: 6 months
Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score
Time frame: 6 months
Average Tear Breakup Time in Seconds
Time frame: 6 months
Average Schirmer I Test in mm
Time frame: 6 months
Average Corneal Staining Score
Time frame: 6 months
Average Conjunctival Staining Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelly K Nichols, OD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HydroEye® in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 1 site 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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 6 Mar 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score (time frame: 6 months). 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 6 Mar 2025.