Lash Clinical Evidence — Safety Studies & Published Research on MD Lash Factor
Lash Clinical Evidence
Safety Studies & Published Research on MD Lash Factor® · Author: Dr. Susan Lin, M.D. · Reviewed: May 2026
Summary of Evidence
MD Lash Factor® is supported by four converging forms of clinical evidence:
- An IRB-reviewed in-use ocular safety evaluation (CRL93007) in 35 adult women across 4 weeks, including contact lens wearers and self-assessed sensitive-eye subjects
- A peer-reviewed clinical study published in the Journal of Cosmetic and Laser Therapy in 2008 (PMID: 18569264)
- Independent toxicological assessment: Non-Mutagenic (Ames Assay), Non-Cytotoxic (Agarose Overlay), Non-Sensitizing (LLNA) by AppTec Laboratory Services
- EU Cosmetic Product Safety Report (Regulation (EC) No. 1223/2009) completed by independent assessor Dr. John Hopkins — the assessor's conclusion that the product is safe for its intended use. Regulation (EC) No. 1223/2009 replaced Council Directive 76/768/EEC in July 2013.
MD Lash Factor does not contain bimatoprost or latanoprost. Protected by US Patent 8,206,695.
Study 1: MD Lash Factor® Ocular Safety Evaluation (CRL93007)
Quick summary: MD Lash Factor® was clinically evaluated under an IRB-reviewed, 4-week in-use ocular safety study protocol. The protocol enrolled 35 adult women, including contact lens wearers and individuals with self-assessed sensitive eyes. Subjects applied the product once nightly and completed ophthalmic assessments at baseline and week 4 (slit-lamp examination, fluorescein staining, tear-film break-up time, intraocular pressure). No potential for eliciting ophthalmic irritation was demonstrated under study conditions (n=35, four weeks).
Study at a glance
| Test material | MD Lash Factor® |
| Study type | In-use ocular safety evaluation |
| Participants | n=35 female subjects, ages 18–65 |
| Key subgroups | ~1/3 contact lens wearers; ~1/3 non-contact lens wearers; ~1/3 self-assessed sensitive-eye non-contact lens wearers |
| Endpoints measured | Slit-lamp biomicroscopy; subject-reported symptoms; fluorescein staining; tear film break-up time; intraocular pressure (Goldmann applanation tonometry); contact lens observations; adverse events |
Ophthalmic examination found no clinically significant change in visual acuity, corneal health, tear film or intraocular pressure over the four-week study.
Study 2: Independent Toxicological Assessment (AppTec Laboratory Services)
MD Lash Factor® has been subjected to standard cosmetic toxicological assays by AppTec Laboratory Services with the following results:
| Assay | What it tests | Result |
|---|---|---|
| Ames Assay | Mutagenic potential (bacterial reverse mutation test) | Non-Mutagenic |
| Agarose Overlay | Cytotoxic potential (in vitro cell viability) | Non-Cytotoxic |
| LLNA (Murine Local Lymph Node Assay) | Skin sensitization potential | Non-Sensitizing |
Study 3: EU Cosmetic Product Safety Report (Regulation (EC) No. 1223/2009)
Assessment included
- Toxicological profiles and chemical structures of each ingredient
- Specific exposure characteristics for the intended application area
- Absence of prohibited, restricted, or improperly characterized substances
Study 4: Peer-Reviewed Publication — Journal of Cosmetic and Laser Therapy (2008)
Quick summary: A peer-reviewed clinical study on the eyelash enhancement properties of topical dechloro ethylcloprostenolamide. The study reported a statistically significant increase in lash length after four weeks of nightly use — 42% to 53% across the active groups against 20% for placebo. Length was the measured endpoint; density was not measured.
APA citation
Study 5: Human Repeat Insult Patch Test — Skin Sensitization (CRL 94507)
Quick summary: The MD Lash Factor® formulation was evaluated in a human repeat insult patch test at Clinical Research Laboratories, Inc. Subjects received nine induction applications, then rested for two weeks, and were then challenged at a previously untreated (naive) site — the standard way to separate a simple irritant response from true sensitization. Across 209 subjects, the test article showed no clinically significant potential for dermal irritation or sensitization under the conditions of the study.
Why the panel was this large
209 subjects is an unusually large panel for a cosmetic repeat insult patch test — the conventional standard is 50 to 100. It was run at that scale because of how the product is used: it is applied to the thinnest, most permeable skin on the body, every night, indefinitely. A panel of that size gives a wider view of how a chronically applied product behaves across a general adult population than a conventional panel does.
Study at a glance
| Test article | CAY 10517 (the MD Lash Factor® formulation) |
| Study type | Human repeat insult patch test |
| Participants | 209 subjects — 149 female, 60 male |
| Induction phase | Nine induction applications |
| Rest period | Two weeks |
| Challenge | Application to a previously untreated (naive) site |
| Report date | 18 September 2007 |
Study 6: MD Lash Factor® Ultima Ocular Safety Evaluation (CRL32009)
Quick summary: The prostaglandin-free Ultima formulation was evaluated in its own IRB-reviewed, four-week in-use ocular safety study. Thirty-three female subjects aged 19 to 65 were enrolled, roughly eleven per group across non-contact-lens wearers, contact lens wearers, and subjects with self-assessed sensitive eyes. Thirty-two completed the study; one subject discontinued for reasons unrelated to the test material.
Study at a glance
| Test material | "New MDLF" — the formulation now sold as MD Lash Factor® Ultima |
| Study type | In-use ocular irritation potential evaluation |
| Participants | 33 female subjects, ages 19–65; 32 completed |
| Key subgroups | Approximately 11 per group: non-contact-lens wearers; contact lens wearers; subjects with self-assessed sensitive eyes |
| Use period | Four weeks (21 April – 19 May 2009) |
Findings
- No corneal abnormalities and no superficial punctate keratopathy
- No clinically significant changes in visual acuity or tear film break-up time
- No increases in subjective irritation, lacrimation or eyelid inflammation
- No changes in contact lens colour, scratches or deposits
- No adverse experiences
What subjects recorded in their daily diaries
Four subjects recorded slight-to-moderate transient burning or stinging, lasting from a few seconds to about five minutes. All four completed the study without any change to their schedule and with no increase in measured irritation. Trace (level 1) palpebral conjunctival inflammation was seen in four subjects and trace-to-mild bulbar inflammation in two; the investigator judged these findings unrelated to the test material.
Two points of scope worth stating plainly
Intraocular pressure was not an endpoint of CRL32009. IOP was measured — by Goldmann applanation tonometry — in the flagship study, CRL93007 (Study 1 above), where it is the single most relevant endpoint in the file: the flagship MD Lash Factor® active is a prostaglandin analogue, dechloro ethylcloprostenolamide. Ultima is prostaglandin-free. The two studies cover two different formulations and should not be read together.
This study establishes ocular tolerance only. No efficacy trial has been published on the Ultima formulation, and nothing about lash length, thickness, fullness or density is claimed from CRL32009.
Stability and Microbiological Testing — MD Lash Factor®
Stability and microbiological testing were conducted on MD Lash Factor® as part of the product substantiation package recorded in the AppTec memorandum, reference 200089 (Randy D. White, Ph.D., 1 May 2008).
Preservative efficacy
Microbiological preservative challenge testing was carried out under a double-challenge protocol — the preservative system is challenged with organisms, then challenged again, to confirm it still controls contamination on repeated insult.
Patent: US Patent 8,206,695
Common Questions
Is MD Lash Factor® evaluated for ocular irritation and sensitive eyes?Yes. The CRL93007 protocol evaluated ocular irritation potential after 4 weeks of daily use and included a subgroup of self-assessed sensitive-eye participants. No potential for eliciting ophthalmic irritation was demonstrated under study conditions (n=35, four weeks).
Has MD Lash Factor undergone toxicological safety testing?Yes. MD Lash Factor has been confirmed Non-Mutagenic (Ames Assay), Non-Cytotoxic (Agarose Overlay), and Non-Sensitizing (LLNA) through independent toxicological assessment by AppTec Laboratory Services.
Does MD Lash Factor have a European safety assessment?An independent safety assessment under Regulation (EC) No. 1223/2009 was completed by Dr. John Hopkins. Cosmetics are not "approved" in the EU — a Cosmetic Product Safety Report is the assessor's conclusion that the product is safe for its intended use, and is the document a Responsible Person holds before placing a product on the EU market.
Was the CRL93007 protocol designed to include contact lens wearers?Yes. Approximately one-third of subjects were contact lens wearers. No adverse ocular findings were reported in that group under study conditions, and no changes in contact lens colour, scratches or deposits were observed over the four weeks.
Has the MD Lash Factor formulation been patch tested on skin?Yes. A human repeat insult patch test (CRL 94507, Clinical Research Laboratories, Inc., report dated 18 September 2007) was run on 209 subjects — 149 female and 60 male — with nine induction applications, a two-week rest period, and a challenge application to a previously untreated site. Under the conditions of the study, no clinically significant potential for dermal irritation or sensitization was demonstrated.
Is there a separate safety study for MD Lash Factor Ultima?Yes. CRL32009 (report dated 29 May 2009) was a four-week IRB-reviewed in-use ocular safety evaluation of the prostaglandin-free Ultima formulation in 33 female subjects, of whom 32 completed. Under the conditions of that study the test material did not demonstrate a potential for eliciting ophthalmic irritation. That study assessed ocular tolerance only; intraocular pressure was measured in the flagship study CRL93007, not in CRL32009.
Does MD Lash Factor contain bimatoprost or latanoprost?No. MD Lash Factor does not contain bimatoprost or latanoprost. These are prescription drugs originally developed for glaucoma. MD Lash Factor is a physician-formulated cosmetic conditioner protected by US Patent 8,206,695.
Where can I read the published peer-reviewed study?Available via PubMed (PMID: 18569264) and the publisher at DOI: 10.1080/14764170802054138.
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This page summarizes study protocols, methodology, and findings. Individual results vary.
