The COAT Trial: Cequa's Onset of Action Trial
Completed · Phase 4
Conditions studied: Dry Eye
In brief
Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
Key facts
- Study ID
- NCT06482177
- Run by
- Research Insight LLC
- People needed
- 52
- Starts
- 2023-10-12
- Expected to finish
- 2024-06-05
- Last updated by the study team
- 2024-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Harvard Eye Associates — Laguna Hills, California, United States
Full record on ClinicalTrials.gov
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