Clinical trial NCT06482177: The COAT Trial: Cequa's Onset of Action Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in corneal high order aberrations (HOA)
timeFrame: After 7, 14, and 28 days of treatment
Secondary outcomes:
measure: Change in corneal staining
timeFrame: After 7, 14, 28 days of treatment
Other outcomes:
measure: Change in best corrected visual acuity
timeFrame: After 7, 14, and 28 days of treatment
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
Study officials:
affiliation: Harvard Eye Associates
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References: