Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

• Status: Terminated
• Trial end date: 2009-06-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ketorolac and Hydroxypropyl Methylcellulose are effective in the treatment of Dry Eye.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ORA, Inc.
• Treatments: Ketorolac; Ketorolac Tromethamine

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.