N/A
Completed N=15
Tear Film Innovations iLux Safety Study
Meibomian Gland Dysfunction · Evaporative Dry Eye
Source: ClinicalTrials.gov NCT03055897 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment — 37.7; 38.5; 38.2 degrees Celsius
Summary
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment |
37.7; 38.5; 38.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Sign written informed consent prior to study participation
Key Exclusion Criteria
- History of ocular surgery within 1 year
- Active ocular infection
- Ocular surface abnormality; lid surface abnormalities
- Pregnant, nursing or not utilizing adequate birth control measures
- Other protocol-specified exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03055897). 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. Informational only — not medical advice.