Expired Study
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Andover, Massachusetts 01810


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

Study summary:

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


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.



Primary Contact:

Principal Investigator
H. Jerome Crampton, MD
Ophthalmic Reserach Associates

Backup Contact:


Location Contact:

Andover, Massachusetts 01810
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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