Evaluation of the Safety and Tolerability of Ocular Lubricants

Launched by ALCON RESEARCH · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and tolerability of three new types of artificial tears for people with moderate dry eye disease. If you often experience dryness, irritation, or discomfort in your eyes, this study might be a good fit for you. To participate, you'll need to be between the ages of 65 and 74, able to understand and agree to the study rules, and currently using regular artificial tears to help with your dry eye symptoms. It's also important that you can attend all scheduled study visits and can keep your environment stable, avoiding extreme weather conditions during the study.

Participants in this trial can expect to use the new eye drops and report how they feel while using them. The study will help researchers determine if these new formulations are safe and effective for people like you. However, there are some criteria that would exclude you from participating, such as having a recent eye injury, ongoing eye infections, or if you wear contact lenses. If you're interested and meet the eligibility requirements, this could be a great opportunity to help improve treatments for dry eye disease!

Gender

ALL

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.