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

• Status: Not yet recruiting
• Trial end date: 2022-12-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Research Insight LLC
• Treatments: Loteprednol Etabonate

Criteria

Inclusion Criteria:

• 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.

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.