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COVID disruptions to recruitment and study completion, unforeseen staffing and other issues
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HydroEye® | Experimental | Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). |
|
| Placebo | Placebo Comparator | Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HydroEye® | Drug | This is an omega-3 fatty acids supplement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months |
| Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly K Nichols, OD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated by the sponsor before completing enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was terminated by the sponsor. Covid impacted recruitment and the active and placebo self-life was exceeded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly K. Nichols | UAB | 205-975-9935 | nicholsk@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2023 | Oct 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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.
The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic. |
| 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. | 6 months |
| Average Tear Breakup Time in Seconds | This is a measure of tear stability with higher values being better (seconds). | 6 months |
| Average Schirmer I Test in mm | This is a measure of tear volume with higher values being better (0 mm - 35 mm). | 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. | 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). | 6 months |
| 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CLDEQ survey | The Contact Lens Dry Eye Questionnaire (the CLDEQ-8) is a survey to evaluate comfort of the eyes while wearing contact lenses. The scale range is 0 to 37 where 0 is good and 37 is worse. | Mean | Standard Deviation | units on a scale |
|
| Number of participants with a non-zero Neuropathic Pain Symptom Inventory (NPSI) Score | On the Neuropathic Pain Symptom Inventory (NPSI), each of the 10 pain descriptor items is rated on a scale from 0 to 10, with a higher score indicating greater severity of neuropathic pain, and the total score is calculated by summing up the scores from all 10 items, resulting in a potential range from 0 to 100; a higher total score signifies more severe neuropathic pain symptoms. | Count of Participants | Participants |
|
| Tear Film Break-up time | Mean | Standard Deviation | seconds |
|
| Schirmer I score | The Schirmer test strip is 35mm in length, so the range is 0-35mm wetting of the strip in 5 min. Low values indicate more severe dry eye (less wetting of strip). | Mean | Standard Deviation | mm |
|
| Corneal Staining | Mean | Standard Deviation | points |
|
| Conjunctival staining | Mean | Standard Deviation | points |
|
| SPEED survey | Mean | Standard Deviation | points |
|
|
|
| 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. | 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. | Posted | Baseline, 6 months |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Average Tear Breakup Time in Seconds | This is a measure of tear stability with higher values being better (seconds). | Posted | Mean | Standard Deviation | seconds | 6 months |
|
|
|
| Secondary | Average Schirmer I Test in mm | This is a measure of tear volume with higher values being better (0 mm - 35 mm). | Posted | Mean | Standard Deviation | mm | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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