Clinical trial NCT06571656: Evaluation of the Safety and Tolerability of Ocular Lubricants
Official title: Evaluation of the Safety and Tolerability of Ocular Lubricants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Keywords: Scratchy eyes
Dry eyes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events (AEs)
timeFrame: 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.
measure: Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
timeFrame: Screening Visit through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Optometry and Vision
state: New South Wales
city: Spring Hill
country: Australia
facility: Advanced Optometry
state: Queensland
city: Teneriffe
country: Australia
facility: Ophthalmic Trials Australia
state: Queensland
city: Carlton
country: Australia
facility: The University of Melbourne, Department of Optometry and Vision Science
state: Victoria
city: Waurn Ponds
country: Australia
facility: Deakin Collaborative Eye Care Clinic
state: Victoria
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Dry Eye
role: STUDY_DIRECTOR
References: