Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

Ora, Inc.

Status and phase: Withdrawn; Phase 2

Conditions: Dry Eye

Treatments: Drug: Vehicle; Drug: Ketorolac/HPMC; Drug: HPMC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03693183

09-004-02

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Ketorolac/HPMC

Experimental group

Description:

Drug: Ketorolac/HPMC Ophthalmic Solution 1 drop administered in each eye 4 times per day for 2 days

Treatment:

Drug: Ketorolac/HPMC

HPMC

Active Comparator group

Description:

Drug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution 1 Drop administered in each eye 4 times per day for 2 days

Treatment:

Drug: HPMC

Vehicle

Placebo Comparator group

Description:

Drug: Vehicle Ophthalmic Solution 1 drop administered in each eye 4 times a day for 2 days

Treatment:

Drug: Vehicle