Evaluation of the Safety and Tolerability of Ocular Lubricants

Alcon Research73 enrolled

Overview

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

This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects. At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2. This study will be conducted in Australia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Disease

Interventions

FID123359 test formulationOTHER

Investigational product

FID123360 test formulationOTHER

Investigational product

FID123361 test formulationOTHER

Investigational product

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Willing and able to understand and sign an Ethics Committee-approved informed consent form. * Willing and able to attend all study visits as required by the protocol. * Exhibits symptoms of dry eye at the Screening Visit. * Currently uses habitual artificial tears to alleviate dry eye symptoms. * Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days. * Other protocol-specified inclusion criteria may apply. Key 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. * Has had an ocular injury to either eye in the past 12 weeks prior to screening. * Currently wears contact lenses or has a history of contact lens wear within the previous 1 month. * Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study. * Is pregnant, intends to become pregnant, or is breastfeeding. * Other protocol-specified exclusion criteria may apply.

Locations (5)

School of Optometry and Vision

Sydney, New South Wales, Australia

Advanced Optometry

Spring Hill, Queensland, 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 the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 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: Screening Visit through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based 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: Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.

Data from ClinicalTrials.gov

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