An Evaluation of the Safety and Tolerability of Ocular Lubricants

N/ANot Yet RecruitingNCT07238699

Alcon Research148 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.

Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

148

Conditions

Dry Eye Disease

Interventions

FID123440 test formulationOTHER

Investigational product

FID123437 test formulationOTHER

Investigational product

FID123440 test formulationOTHER

Investigational product

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must be willing and able to understand and sign an ethics committee approved informed consent form. * Subject must be willing and able to attend all study visits as required by the protocol. * Subject must exhibit symptoms of dry eye at the Screening Visit. * Subject must currently use artificial tears. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Has any known active ocular disease and/or infection. * Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable. * Any ocular injury to either eye in the 12 weeks prior to screening. * Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month. * Other protocol-defined exclusion criteria may apply.

Locations (5)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

School of Optometry and Vision

Sydney, New South Wales, Australia

Ophthalmic Trials Australia

Teneriffe, Queensland, Australia

The University of Melbourne, Department of Optometry and Vision Science

Carlton, Victoria, Australia

Outcomes

Primary Outcomes

Number of Treatment-Emergent Adverse Events (AEs)

An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.

Time frame: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]

Number of Subjects with Biomicroscopy Findings Outside of Normal Limit

The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.

Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

Best Corrected Visual Acuity (BCVA)

BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).

Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

Central Contacts

Alcon Call Center

CONTACT

1-888-451-3937 alcon.medinfo@alcon.com

Data from ClinicalTrials.gov

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