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

NCT ID: NCT05322148

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-03
• Study Completion Date: 2022-11-21

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Insight LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hovanesian, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Eye Associates

Locations

Inland Eye Specialists

Hemet, California, United States

Harvard Eye Associates

Laguna Hills, California, United States

Cleveland Eye Clinic

Brecksville, Ohio, United States

Countries

United States

Other Identifiers

2010 CLEAN Klarity CL

Identifier Type: -

Identifier Source: org_study_id