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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free
Sponsored by
Research Insight LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inland Eye Specialists
  • Harvard Eye Associates
  • Cleveland Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

cyclosporine 0.1% / loteprednol 0.2% group

cyclosporine 0.05% group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary Study Measure - Corneal Higher Order Aberrations by Topography
Change in corneal higher order aberrations after 14 days and 28 days of treatment

Secondary Outcome Measures

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)

Full Information

First Posted
February 17, 2022
Last Updated
December 30, 2022
Sponsor
Research Insight LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05322148
Brief Title
Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization
Acronym
CLEAN
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Insight LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, prospective, randomized controlled, open label study of the efficacy of cyclosporine 0.1% / loteprednol 0.2% in improving higher order aberrations, and TBUT in patients with dry eye. Patients will be randomized to receive treatment with either cyclosporine 0.1% / loteprednol 0.2% BID for 4 weeks or cyclosporine 0.05% BID for 4 weeks and will be evaluated at baseline (before treatment), 14 days, and 28 days of treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cyclosporine 0.1% / loteprednol 0.2% group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cyclosporine 0.05% group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Study Measure - Corneal Higher Order Aberrations by Topography
Description
Change in corneal higher order aberrations after 14 days and 28 days of treatment
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Secondary Measure - SPEED Questionnaire to track progression of dry eye symptoms over time
Description
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)
Time Frame
Up to 2 months
Other Pre-specified Outcome Measures:
Title
Exploratory Outcome Measure
Description
Tolerability score on modified COMTOL scale at 14, and 28 days of treatment.
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hovanesian, MD
Organizational Affiliation
Harvard Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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