Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization

Completed · Phase 3

Conditions studied: Dry Eye

In brief

The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye

Key facts

Study ID

NCT05322148

Run by

Research Insight LLC

People needed

59

Starts

2022-06-03

Expected to finish

2022-11-21

Last updated by the study team

2023-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients over age 18 with the following signs:
• i. Central or inferior corneal fluorescein staining defined by the Oxford Scale ii. Reduced tear break up time (TBUT) ≤ 10 seconds.
• Able to comprehend and sign a statement of informed consent.
• Patients willing to take an electronic survey about their tolerability of either study medication.
• 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

• Inland Eye Specialists — Hemet, California, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States

Full record on ClinicalTrials.gov

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