The COAT Trial: Cequa's Onset of Action Trial

Research Insight

Status and phase

Completed

Phase 4

Conditions

Dry Eye

Treatments

Drug: Cyclosporine ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT06482177

2303

Details and patient eligibility

About

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

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.