The COAT Trial: Cequa's Onset of Action Trial (COAT)

The COAT Trial: Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients

Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Cyclosporine ophthalmic solution

Detailed Description

The purpose of this study is to examine the speed of onset of CEQUA ™ in improving the ocular surface among patients with dry eye.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

*Patients with the following signs: Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.

• Able to comprehend and sign a statement of informed consent.
• Willing and able to complete all required postoperative visits.

Exclusion Criteria:

• Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
• Clinically significant ocular trauma.
• Active ocular Herpes simplex or Herpes Zoster infection
• Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
• Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
• Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
• Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
• Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
• Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
• Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
• Participation in this trial in the same patient's fellow eye
• Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dry Eye Disease; Patient with dry eye disease	Drug: Cyclosporine ophthalmic solution; Cyclosporine BID in the study eye; Other Names: Cequa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in corneal high order aberrations (HOA)	Change in corneal HOA	After 7, 14, and 28 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in corneal staining	Corneal staining	After 7, 14, 28 days of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in best corrected visual acuity	Best corrected visual acuity	After 7, 14, and 28 days of treatment

Collaborators and Investigators

• Sponsor: Research Insight LLC
• Investigators: Principal Investigator: John Hovanesian, MD, Harvard Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): June 5, 2024

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• 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; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 2303

Drug and device information, study documents

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