Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization (CLEAN)

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free

Detailed Description

Thirty million people in the US are thought to suffer from dry eye. Patients with this condition manifest with ocular surface disruption such as corneal fluorescein staining and reduced tear breakup time (TBUT). Successful treatment is a high priority for both patients and physicians, reducing symptoms and improving visual acuity and corneal higher order aberrations (HOAs), which have been closely linked with treatment satisfaction. A number of studies have shown the benefit of both cyclosporine and steroids in managing dry eye. However, existing formulations of these products are challenged by either limited tolerability, a high out-of-pocket cost or both. Combination therapy with these agents in an advanced, more tolerable formulation have the potential to improve both tolerability and cost. However, the available formulation of preservative free Klarity CL (cyclosporine 0.1% and loteprednol 0.2% in a chondroitin sulfate vehicle) has not been studied rigorously.

This study is designed to demonstrate that Klarity CL can benefit the ocular surface with high tolerability, making it a very desirable method of treating patients with dry eye.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cyclosporine 0.1% / loteprednol 0.2% group; 60 total patients will be randomized in a 2 to 1 proportion with 40 in the cyclosporine 0.1% / loteprednol 0.2% group and 20 in the cyclosporine 0.05% group. All patients will undergo treatment in both eyes.	Drug: Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free; A number of studies have shown the benefit of both cyclosporine and steroids in managing dry eye. However, existing formulations of these products are challenged by either limited tolerability, a high out-of-pocket cost or both. Combination therapy with these agents in an advanced, more tolerable formulation have the potential to improve both tolerability and cost. However, the available formulation of preservative free Klarity CL (cyclosporine 0.1% and loteprednol 0.2% in a chondroitin sulfate vehicle) has not been studied rigorously.
Active Comparator: cyclosporine 0.05% group; 60 total patients will be randomized in a 2 to 1 proportion with 40 in the cyclosporine 0.1% / loteprednol 0.2% group and 20 in the cyclosporine 0.05% group. All patients will undergo treatment in both eyes.	Drug: Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free; A number of studies have shown the benefit of both cyclosporine and steroids in managing dry eye. However, existing formulations of these products are challenged by either limited tolerability, a high out-of-pocket cost or both. Combination therapy with these agents in an advanced, more tolerable formulation have the potential to improve both tolerability and cost. However, the available formulation of preservative free Klarity CL (cyclosporine 0.1% and loteprednol 0.2% in a chondroitin sulfate vehicle) has not been studied rigorously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Study Measure - Corneal Higher Order Aberrations by Topography	Change in corneal higher order aberrations after 14 days and 28 days of treatment	Up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Measure - SPEED Questionnaire to track progression of dry eye symptoms over time	SPEED score at baseline, 14, and 28 days of treatment. Slit lamp exam at baseline, 2 weeks and 4 weeks to determine ocular hyperemia (Schulze Scale), tear breakup time (TBUT), cornea staining (Oxford scale)	Up to 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome Measure	Tolerability score on modified COMTOL scale at 14, and 28 days of treatment.	Up to 28 days

Collaborators and Investigators

• Sponsor: Research Insight LLC
• Investigators: Principal Investigator: John Hovanesian, MD, Harvard Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 21, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: 2010 CLEAN Klarity CL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No