Clinical Trial 44304

Fort Lauderdale, FL 33073


Summary:

 Primary: 1. To assess the dose response relationship and optimal therapeutic response of Provinal® in the management of dry eyes in healthy subjects at 30 days of treatment. 2. To assess the efficacy of Provinal® in the management of dry eye signs and symptoms in healthy subjects over 90 days of treatment. 3. To describe the safety of Provinal® in the management of dry eyes in healthy subjects over 90 days of treatment.

Secondary: 1. To assess the efficacy of omega-3 (EPA and DHA) ethyl esters in the management of dry eye signs and symptoms in healthy subjects at 30 days of treatment. 2. To assess the efficacy of omega-3 (EPA and DHA) ethyl esters in the management of dry eye signs and symptoms in healthy subjects over 90 days of treatment. 3. To describe the safety of omega-3 (EPA and DHA) ethyl esters in the management of dry eyes in healthy subjects over 90 days of treatment.



Inclusion Criteria: Subjects are eligible for inclusion into the study if the following criteria are met: 1. Be willing and able to provide written informed consent for the trial. 2. Male or female between 18 years and 50 years of age on day of signing informed consent. 3. Subject presents with active dry eye symptoms. 4. Subject has a score between ≥6 and ≤11 in the Severity Subcategory of the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire. 5. Subject is available for the duration of the study including follow-up (approximately 90 days). 6. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. 7. Female subjects of childbearing potential must agree to use an effective birth control method for the course of the study, defined as: • continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or; • use of an intra-uterine device or implantable contraceptive, or; • use of double barrier methods of birth control. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year. 8. Male subjects must agree to use an adequate method of contraception (as defined above) for the course of the study. 

Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from participation in the study: 1. Subject with uncontrolled eye disease, or with a condition anticipated to interfere with interpretation of study results, as determined by the investigator, will be excluded 2. Subject has dry eye symptoms due to medication use. 3. Subject has active seasonal allergies. 4. Subject has uncontrolled myopia or presbyopia. 5. Subject has eyelid or eyelash abnormalities. 6. Subject is consuming omega-3 fatty acids supplements, omega-3 fortified food, fish/oil supplements, and/or >1 serving per week of fish. • Such subjects can be instructed to stop them and return for re-screening after a 3-week washout period. 7. Subject is being treated with therapies commonly used for dry eye symptoms including, but not limited to, topical cyclosporine, autologous serum, steroid eye drops, and Lacrisert. • Such subjects can be instructed to stop them and return for re-screening after a 3-week washout period. 8. Subject is presently treated or has been treated less than 6 months earlier with chemotherapy or radiotherapy. 9. Subject has a known history of fish or shellfish allergy or hypersensitivity. 10. Have a known psychiatric or substance abuse disorder that would interfere with meeting the requirements of the trial. 11. Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the subject’s participation in the trial, or is not in the best interest of the subject to participate. 12. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting from the baseline visit up to the last trial assessment. 13. Participated in a study with an investigational agent or device within 30 days from enrollment in the current study. 14. The Schirmer’s test value of the subject is ≥ 15mm at baseline visit


Qualified Participants May Receive:

Investigational Product, Dosage, and Mode of Administration: Investigational • Provinal® 420 mg or Provinal®840 mg • Omega-3 ethyl esters 684 mg (438 mg EPA and 246 mg DHA) Placebo • Medium chain triglycerides. All subjects will receive two (2) softgels taken daily before or after breakfast.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.