An Evaluation of the Safety and Tolerability of Ocular Lubricants

NCT07238699 | Recruiting

• 1 other identifier: DEE253-E003
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Dry Eye Disease

Keywords

Itchy eyes; Stinging eyes; Scratchy eyes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

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

Study Arms (2)

Sequence 1: FID123440, then FID123437

EXPERIMENTAL

One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Other: FID123440 test formulation; Other: FID123437 test formulation

Sequence 2: FID123437, then FID123440

EXPERIMENTAL

One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Other: FID123437 test formulation; Other: FID123440 test formulation

Interventions

FID123440 test formulation OTHER

Investigational product

Sequence 1: FID123440, then FID123437

FID123437 test formulation OTHER

Investigational product

Sequence 1: FID123440, then FID123437; Sequence 2: FID123437, then FID123440

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

School of Optometry and Vision

Sydney, New South Wales, 2052, Australia

RECRUITING

Ophthalmic Trials Australia

Teneriffe, Queensland, 4005, Australia

RECRUITING

The University of Melbourne, Department of Optometry and Vision Science

Carlton, Victoria, 3053, Australia

RECRUITING

Deakin Collaborative Eye Care Clinic, Deakin University

Waurn Ponds, Victoria, 3216, Australia

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Clinical Trial Lead, Dry Eye

  Alcon Research, LLC

  STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 20, 2025
• Study Start: March 4, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

AU (4)