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

NCT05322148 | Completed Phase 3 FDA Drug

• 1 other identifier: 2010 CLEAN Klarity CL
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Measure - SPEED Questionnaire to track progression of dry eye symptoms over time

  Up to 2 months

Other Outcomes (1)

• Exploratory Outcome Measure

  Up to 28 days

Study Arms (2)

cyclosporine 0.1% / loteprednol 0.2% group

ACTIVE COMPARATOR

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

cyclosporine 0.05% group

ACTIVE COMPARATOR

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

Interventions

Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free 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; cyclosporine 0.1% / loteprednol 0.2% group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (3)

Inland Eye Specialists

Hemet, California, 92545, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• John Hovanesian, MD

  Harvard Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: April 11, 2022
• Study Start: June 3, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 21, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

US (3)