Efficacy Study of Ketorolac and HPMC to Treat Dry Eye

NCT03693183 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 09-004-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of Ketorolac and HPMC on fluorescein staining using the Ora Calibra® scale.

  Day 0 through Day 9

Study Arms (3)

Ketorolac/HPMC

EXPERIMENTAL

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

Drug: Ketorolac/HPMC

HPMC

ACTIVE COMPARATOR

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

Drug: HPMC

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

Ketorolac/HPMC DRUG

0.30% Ketorolac/0.80%HPMC Ophthalmic solution administered 4 times per day for 2 days

Also known as: Ketorolac/Hydroxypropyl Methylcellulose

Ketorolac/HPMC

HPMC DRUG

0.80% Hydroxypropyl Methylcellulose solution 4 times per day for 2 days

Also known as: Hydroxypropyl Methylcellulose

HPMC

Vehicle DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Ophthalmic Reserach Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ketorolac; Hypromellose Derivatives

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cellulose; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• H. Jerome Crampton, MD

  Ophthalmic Reserach Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: October 2, 2018
• Study Start: March 1, 2009
• Primary Completion: June 15, 2009
• Study Completion: June 15, 2009
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)