The COAT Trial: Cequa's Onset of Action Trial

NCT06482177 | Completed Phase 4 FDA Drug

• 1 other identifier: 2303
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change in corneal high order aberrations (HOA)

  Change in corneal HOA

  After 7, 14, and 28 days of treatment

Secondary Outcomes (1)

• Change in corneal staining

  After 7, 14, 28 days of treatment

Other Outcomes (1)

• Change in best corrected visual acuity

  After 7, 14, and 28 days of treatment

Study Arms (1)

Dry Eye Disease

OTHER

Patient with dry eye disease

Drug: Cyclosporine ophthalmic solution

Interventions

Cyclosporine ophthalmic solution DRUG

Cyclosporine BID in the study eye

Also known as: Cequa

Dry Eye Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• John Hovanesian, MD

  Harvard Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: October 12, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

US (1)