Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 463 for:    KETOROLAC

Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03693183
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Ketorolac/HPMC Drug: HPMC Drug: Vehicle Phase 2

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2009
Actual Primary Completion Date : June 15, 2009
Actual Study Completion Date : June 15, 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




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


Secondary Outcome Measures :
  1. Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale. [ Time Frame: Day 0 through Day 9 ]
    Evaluate fluorescein staining of Ketorolac and HPMC in subjects with dry eye syndrome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693183


Locations
Layout table for location information
United States, Massachusetts
Ophthalmic Reserach Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
Investigators
Layout table for investigator information
Principal Investigator: H. Jerome Crampton, MD Ophthalmic Reserach Associates

Layout table for additonal information
Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT03693183     History of Changes
Other Study ID Numbers: 09-004-02
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: March 2009

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ORA, Inc.:
Dry Eye

Additional relevant MeSH terms:
Layout table for MeSH terms
Ketorolac
Ketorolac Tromethamine
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action