NCT02448043

Brief Summary

Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients. Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on bimatoprost and an observational study of patients on bimatoprost in another center reported that fingernails grew longer and became less brittle using the topical eye drops to the eyes. The purpose of the double-blinded study is to determine whether the application of the eye drops directly to the proximal nail fold of one hand using the opposite hand as a control will result in longer nails, less brittle nails, and reduced eye pressures should any of the medication be absorbed into the systemic circulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

June 4, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2016

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

December 13, 2019

Completed
Last Updated

December 13, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

May 4, 2015

Results QC Date

June 9, 2019

Last Update Submit

November 26, 2019

Conditions

Nail Growth CessationIntraocular Pressure

Keywords

brittleness

Outcome Measures

Primary Outcomes (4)

  • Change From Baseline in Nail Length of Hands

    Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)

    Baseline, 30 days

  • Change From Baseline in Nail Length of Digits

    Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)

    Baseline, 30 Days

  • Intraocular Pressure at 30 Days of Treatment

    IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM

    Between 7:30 AM and 10:00 AM at 30 days post treatment

  • Nail Brittleness at 30 Days of Treatment

    Scale Title: Nail Brittleness (1-4) Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness).

    Baseline, 30 days

Secondary Outcomes (3)

  • Number of Days Until the First Nail Chipped

    Baseline to 30 days

  • Change in Skin Pigmentation on Hands

    Baseline, 30 days

  • Change in Hirsutism on Hands

    Baseline, 30 days

Study Arms (2)

Right Hand Bimatoprost 0.01% drops, Left Hand Placebo

OTHER

* Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days. * Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.

Drug: Bimatoprost 0.01%Other: Placebo: saline

Left Hand Bimatoprost 0.01% drops, Right Hand Placebo

OTHER

* Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days. * Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.

Drug: Bimatoprost 0.01%Other: Placebo: saline

Interventions

Bimatoprost 0.01%DRUG

Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days

Also known as: Lumigan 0.01%
Left Hand Bimatoprost 0.01% drops, Right Hand PlaceboRight Hand Bimatoprost 0.01% drops, Left Hand Placebo
Placebo: salineOTHER

Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days

Left Hand Bimatoprost 0.01% drops, Right Hand PlaceboRight Hand Bimatoprost 0.01% drops, Left Hand Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Normotensive or glaucoma suspects on no ocular medications
  • No manicure within 2 weeks of the study.

You may not qualify if:

  • Individuals on topical or systemic essential fatty acids (EFA's) in hand lotions, creams, ointments, or medication, or on biotin.
  • Digits with signs of nail injury, deformity, or infection.
  • Nail biters, nail polishers, artificial nail wear or gels, and nail and trimming and filing until the study endpoint.
  • Women of childbearing age who are pregnant or who are trying to become pregnant.
  • Individuals with allergies or sensitivity to prostaglandin agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David J. Palmer, MD

Glenview, Illinois, 60026, United States

Location

Related Publications (13)

  • Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001 Feb;119(2):300-1. No abstract available.

    PMID: 11176999BACKGROUND

  • Ziboh VA, Miller CC. Essential fatty acids and polyunsaturated fatty acids: significance in cutaneous biology. Annu Rev Nutr. 1990;10:433-50. doi: 10.1146/annurev.nu.10.070190.002245. No abstract available.

    PMID: 2200473BACKGROUND

  • Khouri AS, Fechtner RD, Zimmerman, TJ. Latanoprost: A New Approach to the Treatment of Glaucoma. Today's Therapeutic Trends 14: 225-240, 1997

    RESULT

  • Woodward DF, Krauss AH, Chen J, Lai RK, Spada CS, Burk RM, Andrews SW, Shi L, Liang Y, Kedzie KM, Chen R, Gil DW, Kharlamb A, Archeampong A, Ling J, Madhu C, Ni J, Rix P, Usansky J, Usansky H, Weber A, Welty D, Yang W, Tang-Liu DD, Garst ME, Brar B, Wheeler LA, Kaplan LJ. The pharmacology of bimatoprost (Lumigan). Surv Ophthalmol. 2001 May;45 Suppl 4:S337-45. doi: 10.1016/s0039-6257(01)00224-7.

    PMID: 11434936RESULT

  • Bean GW, Camras CB. Commercially available prostaglandin analogs for the reduction of intraocular pressure: similarities and differences. Surv Ophthalmol. 2008 Nov;53 Suppl1:S69-84. doi: 10.1016/j.survophthal.2008.08.012.

    PMID: 19038626RESULT

  • Sjoquist B. Human pharmacokinetic studies summary. Pharmacia and Upjohn Company Technical Report 9500155. March 25, 1995.

    RESULT

  • Tan J, Berke S. Latanoprost-induced prostaglandin-associated periorbitopathy. Optom Vis Sci. 2013 Sep;90(9):e245-7; discussion 1029. doi: 10.1097/OPX.0b013e31829d8dd7.

    PMID: 23912967RESULT

  • Wand M, Shields BM. Cystoid macular edema in the era of ocular hypotensive lipids. Am J Ophthalmol. 2002 Mar;133(3):393-7. doi: 10.1016/s0002-9394(01)01412-x.

    PMID: 11915838RESULT

  • Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71. doi: 10.1111/j.1524-4725.2010.01522.x.

    PMID: 20384750RESULT

  • Johnstone MA. Hypertrichosis and increased pigmentation of eyelashes and adjacent hair in the region of the ipsilateral eyelids of patients treated with unilateral topical latanoprost. Am J Ophthalmol. 1997 Oct;124(4):544-7. doi: 10.1016/s0002-9394(14)70870-0.

    PMID: 9323945RESULT

  • Wand M. New side effect of Prostaglandins. Agsocietynet@aaoforums.aao.org. Jan 2015.

    RESULT

  • Seed Oils and Essential Fatty Acids. Retrieved 5/21/12 http://www.naturopathica.com/system/user_files/attachments/7/original/Naturopathica_Seed_Oils.pdf

    RESULT

  • Janis J (ed). Nail bed injuries. Essential of Plastic Surgery: A UT Southwestern Medical Center Handbook. St Louis, MO: Quality Medical Publishing, Inc: 560-567, 2007.

    RESULT

Limitations and Caveats

Nail chipping reduced the N value at the completion of the study. Suggestion is to etch the nail surface to create a mark, then measure from the nail fold to the nail etch at the end of the trial period.

Results Point of Contact

Title
Dr. David J. Palmer
Organization
Department of Ophthalmology, Northwestern University Feinberg School of Medicine
dpalmermd@comcast.net
3126958150

Study Officials

  • David J Palmer, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Ophthalmology

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 19, 2015

Study Start

June 4, 2015

Primary Completion

May 6, 2016

Study Completion

May 6, 2016

Last Updated

December 13, 2019

Results First Posted

December 13, 2019

Record last verified: 2019-11

Locations

US(1)