The COAT Trial: Cequa's Onset of Action Trial

Last updated: June 25, 2024
Sponsor: Research Insight LLC
Overall Status: Completed

Phase

4

Condition

Eyelid Inflammation

Sjogren's Syndrome

Dry Eye Disease

Treatment

Cyclosporine ophthalmic solution

Clinical Study ID

NCT06482177
2303
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgicalprocedure) performed within the last 3 months or at any time that in theinvestigator's clinical judgment if it would interfere with the outcome measures ofthis 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 fungalinfection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelidsincluding hordeolum/stye).

  • Active, systemic, or local disease condition that causes clinically significantocular 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, severeptosis).

  • Ocular surface abnormality that may compromise the corneal integrity (e.g., priorchemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 cornealfluorescein staining, map dot fingerprint dystrophy, or the effect of any otherophthalmic medication that might in the opinion of the investigator compromise theocular 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 pregnantduring participation in the study.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Cyclosporine ophthalmic solution
Phase: 4
Study Start date:
October 12, 2023
Estimated Completion Date:
June 05, 2024

Study 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.

Connect with a study center

  • Harvard Eye Associates

    Laguna Hills, California 92653
    United States

    Site Not Available

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