Clinical trial NCT03693183: Efficacy Study of Ketorolac and HPMC to Treat Dry Eye
Official title: A Double-Masked, Randomized, Single-Center Study Evaluating the Effect of 0.30% Ketorolac/0.80% HPMC, 0.80% HPMC and Vehicle on Symptoms of Dry Eye After Exposure to the Controlled Adverse Environment (CAE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry Eye
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.
timeFrame: Day 0 through Day 9
Secondary outcomes:
measure: Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale.
timeFrame: Day 0 through Day 9
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ophthalmic Reserach Associates
state: Massachusetts
Study officials:
affiliation: Ophthalmic Reserach Associates
name: H. Jerome Crampton, MD
role: PRINCIPAL_INVESTIGATOR
References: