CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

Novaliq

Status and phase

Completed

Phase 3

Conditions

Dry Eye Disease (DED)

Treatments

Drug: CyclASol Ophthalmic Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT04523142

CYS-005

Details and patient eligibility

About

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Full description

Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
Signed ICF (Informed Consent Form)
Subject-reported history of DED in both eyes
Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion criteria

Early termination of CYS-004
Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
Have a history of herpetic keratitis;
Have an ocular or periocular malignancy;
Be unwilling to avoid wearing contact lenses during the trial;
Have any planned ocular or eyelid surgeries during the trial period
Be a woman who is pregnant, nursing or planning a pregnancy
Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
Women of childbearing potential not using an acceptable means of contraception
Presence of known allergy and/or sensitivity to the study drug or its components
Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly