A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye

Inclusion Criteria

• Age of at least 18 and ability to read, understand, and provide written voluntary informed consent on the Ethics Committee approved Informed Consent Form
• Ability and willingness to comply with all treatment and follow-up and study procedures
• Use of tear substitutes for at least 2.5 months prior to inclusion, and agreement to use multidose preservative-free ART (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
• Symptom 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
• At least 1 eye with the following signs of keratoconjunctivitis sicca :
• Tear break-up time of 10 sec (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
• A decimal visual acuity with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
• No systemic treatment or who had received stable systemic treatment (unchanged for 1 month or longer)
• Female subjects had to be into 1 of the following categories:
• Post-menopausal
• Surgically sterile
• Using birth control method throughout the duration of the study
• Female of childbearing potential needed a negative urine pregnancy test result at screening

Exclusion Criteria

• Severe blepharitis
• Severe ocular dryness accompanied by 1 of the following:
• Lid abnormality
• Corneal disease
• Ocular surface metaplasia
• Filamentary keratitis
• Corneal neovascularization
• Use of contact lenses at inclusion or within 90 days prior to study start
• History of ocular surgery, including laser surgery, in either eye within 180 days prior to study start
• History of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
• History of ocular allergic disease or ocular herpes within 1 year prior to study start
• History of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
• Known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
• 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
• Ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
• Expected use of ocular therapy during the study
• Use of topical ocular steroidal or non-steroidal anti-inflammatory medication within 30 days prior to study start
• Expected use of ocular therapy with immunosuppressants during the study or use of ocular immunosuppressants within 90 days prior to study start
• Use of occlusion therapy with non-resorbable lacrimal or punctum plugs within 90 days prior to study start or use of resorbable plugs
• Use or planned use of therapy such as LipiFlow® or BlephEx®
• Breastfeeding females
• Participation in any drug or device clinical investigation within 30 days prior to entry into study and/or during the period of study participation