Dry Eye
Conditions
Keywords
Prostaglandin analog, Eyelash growth, Ocular surface, Tear film stability, Ophthalmic safety
Brief summary
This prospective interventional study investigates the effects of a prostaglandin analog-based eyelash serum on ocular surface integrity, tear film stability, and eyelash growth over six weeks. Nineteen healthy female participants applied the serum daily, with clinical assessments performed at baseline and post-treatment. The study adhered to ethical guidelines, and parameters such as tear film stability, tear volume, ocular hyperemia, and eyelash characteristics were evaluated.
Interventions
OTHERProstaglandin Analog-Based Eyelash Serum
This intervention consists of a prostaglandin analog-based eyelash serum applied once daily to the upper eyelid margin for six weeks. The serum contains dechloro dihydroxy difluoro ethylcloprostenolamide (DDDE), a prostaglandin analog known to promote eyelash growth. The formulation also includes panax ginseng root extract, urtica dioica extract, panthenol, niacinamide, and biotinoyl tripeptide-1, which contribute to hair follicle nourishment. The study evaluates its effects on ocular surface integrity, tear film stability, and eyelash growth.
Sponsors
University of Seville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a prospective, interventional study evaluating the effects of a prostaglandin analog-based eyelash serum on ocular surface integrity, tear film stability, and eyelash growth over six weeks. All participants applied the serum daily, and clinical assessments were performed at baseline and post-treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Female individuals aged 18 to 30 years. * Corrected distance visual acuity (CDVA) of 0.10 LogMAR or better in both eyes. * Fitzpatrick skin type III or lower. * No active dermatological conditions affecting the periocular area. * Regular use of cosmetic products (e.g., mascara, eyeliner, or eyeshadow) with no history of intolerance. * Willingness and ability to follow the serum application protocol for six weeks.
Exclusion criteria
* History or diagnosis of dry eye disease or other ocular surface disorders. * Previous ocular surgery, trauma, or systemic conditions affecting ocular surface function. * Use of topical or systemic medications that could impact tear film stability. * Documented hypersensitivity or allergic reactions to cosmetic or ophthalmic products. * Presence of eyelid disorders that could interfere with eyelash growth (e.g., blepharitis, trichiasis). * Use of growth-enhancing serums within the past three months. * Pregnancy or breastfeeding at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application | Baseline and after six weeks of serum application | Assessment of average non-invasive tear break-up time (A-NIBUT) as an indicator of tear film stability before and after six weeks of daily prostaglandin analog-based eyelash serum application. A-NIBUT is measured using the Firefly S390I slit lamp (MediWorks, Suzhou, China), with lower values indicating increased tear film instability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Volume (Tear Meniscus Height - TMH) After Six Weeks | Baseline and after six weeks | Measurement of tear meniscus height (TMH) before and after six weeks of eyelash serum application using the Firefly S390I slit lamp to assess changes in aqueous tear volume. Lower TMH values indicate a reduction in tear production. |
| Change in Ocular Hyperemia (Conjunctival and Ciliary Hyperemia) After Six Weeks | Baseline and after six weeks | Evaluation of temporal conjunctival hyperemia (TCOH) and temporal ciliary hyperemia (TCIH) using digital image analysis. An increase in hyperemia suggests a vasodilatory response to the serum. |
| Change in Eyelash Length and Thickness After Six Weeks | Baseline and after six weeks | Measurement of eyelash length and thickness before and after six weeks using caliper software on the Firefly S390I slit lamp to determine the efficacy of the serum in promoting eyelash growth. |
Countries
Spain
Outcome results
None listed