Efficacy Study of Ketorolac and HPMC to Treat Dry Eye
- Registration Number
- NCT03693183
- Lead Sponsor
- ORA, Inc.
- Brief Summary
The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye.
- Detailed Description
This is a double masked, randomized study with approximately 45 subjects randomized to one of the three treatment arms at a single site. There are 5 visits over the course of 16 days.
Visit 1: Day -7 Visit 2: Day 0 Visit 3: Day 2 Visit 4: Day 7 Visit 5: Day 9
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Provide written informed consent;
- Are 18 years of age or older;
- Are able and willing to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;
- Have a corrected visual acuity LogMar +0.7 (ETDRS) or better in each eye;
- Have a reported history of dry eye in each eye;
- Have a history of use of or a desire to use an eye drop for dry eye symptoms within the past 6 months;
- Have a central corneal sensitivity score greater than 55 mm in each eye at Visit 1;
- Have an average diary reported score for ocular discomfort, burning, dryness, grittiness, or stinging of ≥ 1.5 during the one week run-in period between Visits 1 and 2;
- Have a greater than or equal to 1 fluorescein staining score in any region in at least one eye prior to exposure to the CAE at Visit 1;
- Report greater than or equal 3 in worst symptom for all diary entries between visits 2 and 3
- If female and of childbearing potential. Are not pregnant, nursing, or planning a pregnancy. Women of childbearing potential are required to have a negative urine pregnancy test at the screening and exit visits and agree to use an acceptable method of contraception for the duration of the study.
- Have contraindications to the use of the study medication(s);
- Have a known allergy or sensitivity to the study medication(s) or their components;
- Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator;
- Are diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis);
- Wear contact lenses within 1 week of Visit 1 or throughout the duration of the study;
- Have previously had laser in situ keratomileusis (LASIK) surgery;
- Are currently taking any topical ophthalmic prescriptions or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and cannot discontinue these medications 2 hours prior to Visit 1 and for the duration of the trial;
- Have used Restasis® within 30 days of Visit 1;
- Have a systemic disease, or uncontrolled medical condition, that in the opinion of the investigator could interfere with study measurements or subject compliance;
- Are currently taking (at Visit 1) any medication known to cause ocular drying that has not been used on a stable dosing regimen for 30 days prior to Visit 1;
- Are currently pregnant, nursing, or planning a pregnancy;
- (For women of childbearing potential) Are unwilling to submit a urine sample for a pregnancy test at Visit 1 and at exit visit;
- Have received another experimental drug or device within 30 days of Visit 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Drug: Vehicle Ophthalmic Solution 1 drop administered in each eye 4 times a day for 2 days Ketorolac/HPMC Ketorolac/HPMC Drug: Ketorolac/HPMC Ophthalmic Solution 1 drop administered in each eye 4 times per day for 2 days HPMC HPMC Drug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution 1 Drop administered in each eye 4 times per day for 2 days
- Primary Outcome Measures
Name Time Method Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale. Day 0 through Day 9 Evaluate the symptoms of Ketorolac and HPMC on ocular discomfort in subjects with dry eye syndrome.
- Secondary Outcome Measures
Name Time Method Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale. Day 0 through Day 9 Evaluate fluorescein staining of Ketorolac and HPMC in subjects with dry eye syndrome.
Related Research Topics
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Trial Locations
- Locations (1)
Ophthalmic Reserach Associates
🇺🇸Andover, Massachusetts, United States
Ophthalmic Reserach Associates🇺🇸Andover, Massachusetts, United States