efficacy study of ketorolac and hpmc to treat dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to determine whether ketorolac and hydroxypropyl methylcellulose are effective in the treatment of dry eye.

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

Eligibility criteria:
inclusion criteria: 1. provide written informed consent; 2. are 18 years of age or older; 3. 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; 4. have a corrected visual acuity logmar +0.7 (etdrs) or better in each eye; 5. have a reported history of dry eye in each eye; 6. have a history of use of or a desire to use an eye drop for dry eye symptoms within the past 6 months; 7. have a central corneal sensitivity score greater than 55 mm in each eye at visit 1; 8. 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; 9. 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; 10. report greater than or equal 3 in worst symptom for all diary entries between visits 2 and 3 11. 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. exclusion criteria: 1. have contraindications to the use of the study medication(s); 2. have a known allergy or sensitivity to the study medication(s) or their components; 3. have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator; 4. are diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis); 5. wear contact lenses within 1 week of visit 1 or throughout the duration of the study; 6. have previously had laser in situ keratomileusis (lasik) surgery; 7. 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; 8. have used restasis® within 30 days of visit 1; 9. have a systemic disease, or uncontrolled medical condition, that in the opinion of the investigator could interfere with study measurements or subject compliance; 10. 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; 11. are currently pregnant, nursing, or planning a pregnancy; 12. (for women of childbearing potential) are unwilling to submit a urine sample for a pregnancy test at visit 1 and at exit visit; 13. have received another experimental drug or device within 30 days of visit 1.

Keywords: dry eye