Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

Phase 2

Withdrawn

• Conditions: Dry Eye
• Interventions: Drug: Vehicle; Drug: Ketorolac/HPMC; Drug: HPMC

• Registration Number: NCT03693183
• Lead Sponsor: ORA, Inc.

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

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-06-15
• Study Completion: 2009-06-15
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Drug: Vehicle Ophthalmic Solution 1 drop administered in each eye 4 times a day for 2 days
Ketorolac/HPMC	Ketorolac/HPMC	Drug: Ketorolac/HPMC Ophthalmic Solution 1 drop administered in each eye 4 times per day for 2 days
HPMC	HPMC	Drug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution 1 Drop administered in each eye 4 times per day for 2 days

Primary Outcome Measures

Name	Time	Method
Efficacy of Ketorolac and HPMC on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.	Day 0 through Day 9	Evaluate the symptoms of Ketorolac and HPMC on ocular discomfort in subjects with dry eye syndrome.

Secondary Outcome Measures

Name	Time	Method
Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale.	Day 0 through Day 9	Evaluate fluorescein staining of Ketorolac and HPMC in subjects with dry eye syndrome.

Trial Locations

Locations (1)

Ophthalmic Reserach Associates; 🇺🇸 Andover, Massachusetts, United States