Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

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

Detailed Description
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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

Official Title
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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)

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Ketorolac/HPMC
* Drug: HPMC
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent; Are 18 years of age or older; 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; Have a corrected visual acuity LogMar +0.7 (ETDRS) or better in each eye; Have a reported history of dry eye in each eye; Have a history of use of or a desire to use an eye drop for dry eye symptoms within the past 6 months; Have a central corneal sensitivity score greater than 55 mm in each eye at Visit 1; 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; 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; Report greater than or equal 3 in worst symptom for all diary entries between visits 2 and 3 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: Have contraindications to the use of the study medication(s); Have a known allergy or sensitivity to the study medication(s) or their components; Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator; Are diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis); Wear contact lenses within 1 week of Visit 1 or throughout the duration of the study; Have previously had laser in situ keratomileusis (LASIK) surgery; 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; Have used Restasis® within 30 days of Visit 1; Have a systemic disease, or uncontrolled medical condition, that in the opinion of the investigator could interfere with study measurements or subject compliance; 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; Are currently pregnant, nursing, or planning a pregnancy; (For women of childbearing potential) Are unwilling to submit a urine sample for a pregnancy test at Visit 1 and at exit visit; Have received another experimental drug or device within 30 days of Visit 1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye