Evaluation of the Safety and Tolerability of Lumify Eye Illuminations Cosmetic Products
Bibliographic record
Abstract
Purpose: Cosmetic products applied to the periocular area can cause skin sensitivity reactions, and manufacturers routinely test the safety and tolerability of products in development. This research was sponsored by Bausch + Lomb to evaluate three Lumify Eye Illuminations products: a lash and brow serum, a hydra-gel eye cream, and a micellar water eye makeup remover. Methods: A cumulative irritation test (CIT) study and a repeated insult patch test (RIPT) study enrolled adult males or females with no known sensitivities to cosmetic products. Three clinical safety studies enrolled adult females with self-reported characteristics targeted by each product, which was applied in a manner consistent with expected use for 8 or 12 weeks. Results: In CIT (n=34) and RIPT (n=201) studies, faint/minimal erythema reactions were observed in 0% to 2.9% of participants; there were no moderate or severe reactions. No safety signals were observed in participants who completed clinical safety studies for lash and brow serum (n=66 enrolled, n=55 completed [83%]), eye cream (n=61 enrolled, n=52 completed [85%]), or eye makeup remover (n=80 enrolled, n=68 completed [85%]). No clinically relevant changes in visual acuity or ophthalmologic slit-lamp examination findings were noted. No participants reported ocular sensations of burning/stinging, foreign-body sensation, or soreness. At the final clinical safety study assessment, mild cutaneous erythema (as graded by the investigator) was reported for one participant (eye cream study); no other prespecified signs of cutaneous irritation (eg, edema, dryness) were observed. A treatment-related adverse event that led to study discontinuation was experienced by one participant in the eye makeup remover study (bilateral periorbital swelling). Conclusion: Findings from rigorously conducted irritation testing and clinical safety studies indicated that these products were safe and well tolerated. Increased availability of data regarding ocular and cutaneous safety of cosmetic products can inform consumer decision-making and eye care provider recommendations.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".