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

Dry Eye Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322148
• Other study ID #: 2010 CLEAN Klarity CL
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2022
• Est. completion date: November 21, 2022

Study information

• Verified date: December 2022
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 21, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Inland Eye Specialists	Hemet	California
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome Measure	Tolerability score on modified COMTOL scale at 14, and 28 days of treatment.	Up to 28 days
Primary	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	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