A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye

Inclusion Criteria

• Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent
• Subjects must be able to read, understand, and provide written informed consent on the Ethics Committee (EC) approved ICF
• Subjects who are able and willing to comply with all treatment and follow-up, study procedures
• Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use multidose preservative-free artificial tear (Aqualarm U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization
• Subjects with a score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light
• Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca :
• Tear break-up time of ≤ 10sec (mean of 3 measurements) at both screening visit and inclusion visit
• Total ocular surface staining score ≥ 4 and ≤ 9 at both screening visit and inclusion visit. This assessment combines corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme
• Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
• Subjects with no systemic treatment or who are receiving stable systemic treatment (unchanged for 1 month or longer)
• Female subjects who are not of childbearing potential or who have a negative urine pregnancy test result at screening

Exclusion Criteria

Ocular Exclusion Criteria

• Subjects with moderate or severe blepharitis defined by at least moderate (a score of ≥ 2 from a range of 0 to 3) eyelid margin hyperemia or moderate eyelid swelling or both and at least moderate eyelid debris or moderate plugging of meibomian glands or both
• Subjects who have severe ocular dryness accompanied by one of the following:
• Lid abnormality (except mild blepharitis)
• Corneal disease
• Ocular surface metaplasia
• Filamentary keratitis
• Corneal neovascularization
• Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
• Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start
• Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
• Subjects with a history of ocular allergic disease or ocular herpes within 1 year prior to study start
• Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis

Treatment Exclusion Criteria

• Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
• Subjects with initiation of, or changes to, concomitant medication that could affect dry eye within 30 days prior to Visit 1 (Screening) or with planned initiation or changes of such medications during the study
• Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
• Subjects expected to receive ocular therapy during the study
• Subjects treated with topical ocular steroidal or non-steroidal antiinflammatory medication within 30 days prior to study start
• Subjects expected to receive ocular therapy with immunosuppressants (e.g. cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start
• Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start

General Exclusion Criteria

• Female subjects who are sexually active and who do not fall into 1 of the following categories:
• Post-menopausal
• Surgically sterile
• Using o