The COAT Trial: Cequa's Onset of Action Trial

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: Cyclosporine ophthalmic solution

• Registration Number: NCT06482177
• Lead Sponsor: Research Insight LLC

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

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 Timeline

• Study Start: 2023-10-12
• Status Verified: 2024-06
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-05
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dry Eye Disease	Cyclosporine ophthalmic solution	Patient with dry eye disease

Primary Outcome Measures

Name	Time	Method
Change in corneal high order aberrations (HOA)	After 7, 14, and 28 days of treatment	Change in corneal HOA

Secondary Outcome Measures

Name	Time	Method
Change in corneal staining	After 7, 14, 28 days of treatment	Corneal staining

Trial Locations

Locations (1)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States