Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

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)

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

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Vehicle; Drug: Ketorolac/HPMC; Drug: HPMC

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Ophthalmic Reserach Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac/HPMC; Drug: Ketorolac/HPMC Ophthalmic Solution 1 drop administered in each eye 4 times per day for 2 days	Drug: Ketorolac/HPMC; 0.30% Ketorolac/0.80%HPMC Ophthalmic solution administered 4 times per day for 2 days; Other Names: Ketorolac/Hydroxypropyl Methylcellulose
Active Comparator: HPMC; Drug: 0.80% Hydroxypropyl Methylcellulose(HMPC) Ophthalmic Solution 1 Drop administered in each eye 4 times per day for 2 days	Drug: HPMC; 0.80% Hydroxypropyl Methylcellulose solution 4 times per day for 2 days; Other Names: Hydroxypropyl Methylcellulose
Placebo Comparator: Vehicle; Drug: Vehicle Ophthalmic Solution 1 drop administered in each eye 4 times a day for 2 days	Drug: Vehicle; Vehicle

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ORA, Inc.
• Investigators: Principal Investigator: H. Jerome Crampton, MD, Ophthalmic Reserach Associates

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 15, 2009
• Study Completion (Actual): June 15, 2009

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Dry Eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: 09-004-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No