Contact Lens Complication, Dry Eye
Conditions
Keywords
HydroEye®, Contact Lens Discomfort, Dry Eye, Supplement
Brief 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. 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.
Interventions
DRUGHydroEye®
This is an omega-3 fatty acids supplement.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The proposed research study is a randomized, double-masked, controlled clinical trial to test the efficacy of HydroEye® nutraceutical in subjects with contact lens discomfort.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Provide informed consent and authorization to disclose protected health information 3. Willing to follow study protocol 4. Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye 5. 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 6. Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses 7. Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12) 8. Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report 9. Clinical assessment that contact lens material, fit, prescription, and care system are not reasons for contact lens discomfort 10. Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2 11. 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.
Exclusion criteria
1. Meibomian gland dropout ≥75% in either eyelid 2. 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 3. Any systemic disease known to be associated with dry eye 4. 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. 5. Any overnight wear of contact lenses or use of daily disposable contact lenses 6. Any previous corneal surgery, including all types of corneorefractive surgery 7. Have temporary and/or permanent punctal plugs inserted 8. Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days 9. Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week). 10. 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 11. Allergy or intolerance to fish or any ingredients contained in the active or placebo formulas \[See appendix or ingredient list\] 12. Participation in a clinical trial in the past 30 days 13. Current pregnancy or breast feeding as indicated by self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 6 months | The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score | 6 months | The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic. |
| Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score | 6 months | 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. |
| Average Tear Breakup Time in Seconds | 6 months | This is a measure of tear stability with higher values being better (seconds). |
| Average of Tear LTB4 Levels in Picograms Per Milliliter | Baseline, 6 months | 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. |
| Average Corneal Staining Score | 6 months | 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. |
| Average Conjunctival Staining Score | 6 months | This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18). |
| Average Schirmer I Test in mm | 6 months | This is a measure of tear volume with higher values being better (0 mm - 35 mm). |
Countries
United States
Participant flow
Recruitment details
n=31 patients consented and examined n=12 patients randomized/completed (18 screen fails, one discontinued prior to randomization) The study was terminated by the sponsor prior to completing recruitment due to a variety of events including haulted COVID recruitment and manufacturing of the active and placebo formulations. The shelf-life of the initial batches of active and control/placebo expired.
Participants by arm
| Arm | Count |
|---|---|
| HydroEye® Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
HydroEye®: This is an omega-3 fatty acids supplement.
n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued)
n=6 active (A) | 6 |
| Placebo Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
HydroEye®: This is an omega-3 fatty acids supplement.
n=31 patients completed consent and were examined n=12 patients randomized/completed (18 screen fails, one discontinued)
n=6 placebo (P) | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | HydroEye® | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| CLDEQ survey | 23.7 units on a scale STANDARD_DEVIATION 4.2 | 23.5 units on a scale STANDARD_DEVIATION 6.2 | 23.6 units on a scale STANDARD_DEVIATION 5 |
| Conjunctival staining | 2.2 points STANDARD_DEVIATION 1.8 | 2.2 points STANDARD_DEVIATION 1.2 | 2.2 points STANDARD_DEVIATION 1.6 |
| Corneal Staining | 3.2 points STANDARD_DEVIATION 2.1 | 2.8 points STANDARD_DEVIATION 1.2 | 3.0 points STANDARD_DEVIATION 2.3 |
| Number of participants with a non-zero Neuropathic Pain Symptom Inventory (NPSI) Score | 1 Participants | 1 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Schirmer I score | 19.8 mm STANDARD_DEVIATION 12.5 | 24.5 mm STANDARD_DEVIATION 10.8 | 22.2 mm STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| SPEED survey | 10.2 points STANDARD_DEVIATION 2.9 | 7.5 points STANDARD_DEVIATION 4 | 8.8 points STANDARD_DEVIATION 2.9 |
| Tear Film Break-up time | 14.8 seconds STANDARD_DEVIATION 11.2 | 13.6 seconds STANDARD_DEVIATION 6.3 | 14.2 seconds STANDARD_DEVIATION 8.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HydroEye® | Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 15.0 score on a scale | Standard Deviation 2.6 |
| Placebo | Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score | 11.3 score on a scale | Standard Deviation 6.4 |
Secondary
Average Conjunctival Staining Score
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HydroEye® | Average Conjunctival Staining Score | 1.3 units on a scale | Standard Deviation 2 |
| Placebo | Average Conjunctival Staining Score | 2.5 units on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HydroEye® | Average Corneal Staining Score | 3.3 units on a scale | Standard Deviation 2.7 |
| Placebo | Average Corneal Staining Score | 3.3 units on a scale | Standard Deviation 3.9 |
Secondary
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.
Time frame: Baseline, 6 months
Population: This lab test was not performed. There was insufficient tears collected to do the analysis due to the sponsor cancelling the study before adequate enough samples could be collected. Due to study termination and the prohibitive costs of performing the laboratory testing, samples collected from 12 participants, approximately 1/4 the number needed to justify processing the samples based on an a priori power analysis, were never assayed and will never be assayed.
Secondary
Average Schirmer I Test in mm
This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HydroEye® | Average Schirmer I Test in mm | 22.8 mm | Standard Deviation 13 |
| Placebo | Average Schirmer I Test in mm | 21.7 mm | Standard Deviation 14.6 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HydroEye® | Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score | 4.8 score on a scale | Standard Deviation 1.7 |
| Placebo | Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score | 4.7 score on a scale | Standard Deviation 3.3 |
Secondary
Average Tear Breakup Time in Seconds
This is a measure of tear stability with higher values being better (seconds).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HydroEye® | Average Tear Breakup Time in Seconds | 16.0 seconds | Standard Deviation 15.6 |
| Placebo | Average Tear Breakup Time in Seconds | 8.3 seconds | Standard Deviation 2.7 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HydroEye® | Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score | 0 Participants |
| Placebo | Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score | 1 Participants |