Table 5.
Characteristics of included trials.
| Study ID | Country, setting |
Target population |
Age, years mean ± SD (range) |
Female, n/N (%) |
Major race/ ethnicity, n/ N (%) |
Intervention (formula) | Comparison | Treatment duration |
No. randomized/ analyzed, Intervention group |
No. randomized/ analyzed, Comparison group |
No. analyzed for AE, Intervention/ Comparison |
Note |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parallel design | ||||||||||||
| Borchert 2016 | USA & Brazil, multi-site | Mixeda | 14.5 (5–17)/14.6 (8–17) | 53/71 (75) | White, 46/71 (65) | Bimatoprost 0.03% (soln) | Vehicle | 4 months | 48/48 | 23/23 | 48/23 | Eyelash parameters measured by DIA; industry-funded; NCT01023841 (clinicaltrials.gov); additional 1-month follow-up period after DC treatment |
| Glaser 2015 | US & UK, multi-site | Clinical patients | 49.3 ± 11.1 | 235/238 (98.7) | White, 202/238 (84.9) | Bimatoprost 0.03% (soln) | Vehicle | 6 monthse | 179/179 | 59/59 | 118/59 | Eyelash parameters measured by DIA; industry-funded; NCT00907426 (clinicaltrials.gov); reported data for participants with idiopathic hypotrichosis; 3-arm studyb |
| Wirta 2015 | US & UK, multi-site | Clinical patients | 50.7 (26–76) | 129/130 (99.2) | Caucasian, 103/130 (79.2) | Bimatoprost 0.03% (soln) | Vehicle | 6 monthse | 96/96 | 34/34 | 96/33 | Eyelash parameters measured by DIA; industry-funded; NCT00907426 (clinicaltrials.gov); reproted data for participants with postchemotherapy hypotrichosis |
| Harii 2014(study1) | Japan, multi-site | Clinical patients | 40.1 (28–76)/41.4(20–64) | 155/173 (89.6) | Asian, 173/173 (100) | Bimatoprost 0.03% (soln) | Vehicle | 4 months | 88/88 | 85/85 | NR/NR | Eyelash parameters measured by DIA; industry-funded; reported results of two trials: study 1 with an initial target enrollment of 126 participants; “the safety population, which consisted of all the subjects who received at least one dose of study medication" |
| Harii 2014 (study2) | Japan, multi-site | Clinical patients | 46.3 (31–61)/54.9 (39–74) | 36/36 (100) | Asian, 36/36 (100) | Bimatoprost 0.03% (soln) | Vehicle | 4 months | 18/18 | 18/18 | NR/NR | Eyelash parameters measured by DIA; industry-funded; reported results of two trials: study 2 was a safety trial, “not powered for efficacy”; “the safety population, which consisted of all the subjects who received at least one dose of study medication" |
| Smith 2012 | US & Canada, multi-site | Healthy volunteers | 49.9 (22–77)/49.7 (22–78) | 270/278 (97.1) | White, 225/278 (80.9) | Bimatoprost 0.03% (soln) | Vehicle | 16 weeks | 137/137 | 141/141 | 137/141 | Eyelash parameters measured by DIA; industry-funded; NCT00693420 (clinicaltrials.gov); additional visit at week 20 (4 weeks after DC treatment) |
| Woodward 2010 | US, single site | Healthy volunteers | 49.2 (27–69) | 51/52 (98) | NR | Bimatoprost 0.03% (gel) | Vehicle | 6 months | 36/36 | 16/16 | 36/16 | Eyelash parameters measured by DIA; funded by Research to Prevent Blindness, Inc. and Duke University Eye Center; mean IOP at baseline and month 6 were compared between two groups |
| Fabbrocini 2019 | Italy, single site | Clinical patients | 42.25 ± 16 (Range 25–69) | 40/40 (100) | NR | 15-keto fluprostenol isopropyl ester (gel) | Vehicle | 60 days | 20/30 | 20/20 | 20/20 | Eyelash parameters measured by DIA; sources of funding NR |
| Paired-eye design | ||||||||||||
| Wester 2010 | US, single site | Healthy volunteers | 46 (23–69) | 19/19 (100) | NR | Bimatoprost 0.03% (gel) | Normal saline mixed 1:1 with Gonakd | 6 weeks | 19/15 (eyes) | 19/15 (eyes) | 15 | Eyelash parameters measured by DIA; funded by Research to Prevent Blindness, Inc. and NEI; NCT00773136 (clinicaltrials.gov); mean changes in IOP at week 6 were reported for both groups with no differences (P = 1.00) |
| Morris 2011 | US, single site | Clinical patients | Median 50 (Range 31–66) | 20/20 (100) | Caucasian, 16/18 (89) | Bimatoprost 0.03% (gel) | No treatment | 3 months | 20/13 (eyes) | 20/13 (eyes) | 13 | Eyelash parameters measured by DIA; funded by Duke University; NCT01200251 (clinicaltrials.gov); “two patients withdrew from the study unrelated to the eyelash gel” and were excluded from the analysis |
| Qualitative synthesis only | ||||||||||||
| Cohen 2013 | US, multi-site | Clinical patients | NR | NR | NR | Bimatoprost 0.03% (soln) | Placebo | 16 weeks | 44/NR | 44/NR | NR/NR | Industry-funded; a conference proceeding |
| Roseborough 2009 | US, single | Clinical patients | NR | NR | NR | Latanoprost (soln) | Bimatoprost | 16 weeks | NR/NR | NR/NR | NR/NR | Eyelash parameters measured by DIA; funding source none reported; a Research Letter; overall, “11 patients completed the study" |
| Choy 2008 | US, single | Healthy volunteers | (Range 20–56) | 33/34 (97) | NR | Dechloro ethylcloprostenolamide | Placebo | 4 weeks | 23/NR (eyes) | 11/NR (eyes) | 34 | La Canada Ventures, Inc; all authors reported conflicts of interests with the testing product |
| Faghihi 2009 | Iran, single site | Clinical patients | 22.5 ± 7.6 (Range 11–40) | 12/26 (46) | NR | Latanoprost (soln) | No treatment | 4 months | 26/26 (eyes) | 26/26 (eyes) | 26 | None reported; a Brief report |
Abbreviations: AE, adverse events; DIA, digital image analyzer; DC, discontinue; No., number; NR, not reported; SD, standard deviation; soln, ophthalmic solution.
a
Mixture of clinical patients and healthy volunteers.
b
Randomization ratio of 2:1 to bimatoprost 0.03% vs vehicle, with one intervention arm receiving bimatoprost for 12 months and the other for 6 months followed by a cross-over to vehicle in the second 6-month period.
c
MD Lash Factor contains no prostaglandin analogue, and was provided in full strength, half-strength, or quarter strength in (intervention) groups A, B, D; group C was placebo.
d
Gonake (Akorn Inc., Lake Forest, IL).
e
Outcome and safety data were extracted from the end of the first 4 or 6 month after randomization.