N/A
N=161
Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT06444516 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change From Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30 — -16.95 score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID123300 ocular lubricant (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30 |
-16.95 | <.0001 sig |
Summary
The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to understand and sign an approved informed consent form.
- Exhibit symptoms of dry eye at the Screening visit.
- Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
- Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Ocular abnormalities that could adversely affect the safety or efficacy outcome.
- Uncontrolled active systemic diseases.
- Use of systemic medications known to cause dry eye.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06444516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.