Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects

Abstract

Objective: To evaluate long-term efficacy and safety of bimatoprost for treatment of chemotherapy-induced eyelash hypotrichosis.

Design: One-year, multicenter, double-masked, parallel-group study.

Setting: Twenty-one centers in the United States and one center in the United Kingdom.

Participants: This study randomized (3:1) 130 subjects to bimatoprost 0.03% or vehicle applied topically to upper eyelid margins for six months. All subjects used bimatoprost for a second six months.

Measurements: Responders for the primary composite end point achieved ≥1-grade improvement in Global Eyelash Assessment score and ≥3-point improvement in Confidence, Attractiveness, and Professionalism domain score of the Eyelash Satisfaction Questionnaire at Month 4. Secondary assessments included eyelash length, thickness, and darkness, using digital image analysis.

Results: The responder rate was significantly higher with bimatoprost versus vehicle at Month 4 (37.5% vs. 18.2%; p=0.041) and Month 6 (46.9% vs. 18.2%; p=0.004). Significant improvements favoring bimatoprost occurred in eyelash length (p=0.008), thickness (p<0.001), or darkness (p=0.029) at Month 4, with similar results at Month 6 (p<0.001, length; p<0.001, thickness; p=0.002, darkness). Responder rates reached 61.5 percent at Month 12 for subjects continuing bimatoprost and 67.6 percent for those switched from vehicle to bimatoprost. Conjunctival hyperemia (16.7%) and punctate keratitis (9.4%) were the most common adverse events.

Conclusion: Bimatoprost provides rapid eyelash recovery, whether started shortly after chemotherapy (4 to 12 weeks) or delayed for six months, with minimal adverse events.

Clinical trial registry: NCT00907426.

Figures

Figure 1.

Patient disposition. TP=treatment period; TP1=Months 1 to 6; TP2=months 7 to 12. *Includes two subjects randomized in error. †One subject randomized in error did not receive treatment.

Figure 2.

Responders for the composite primary analysis (both a ≥1-grade improvement from baseline in Global Eyelash Assessment (GEA) score and a ≥3-point improvement from baseline in total score on Domain 2 (Confidence, Attractiveness, and Professionalism) of the Eyelash Satisfaction Questionnaire (A) and for each component of the primary analysis separately (B and C). Bim=bimatoprost; veh=vehicle

Figure 2.

Responders for the composite primary analysis (both a ≥1-grade improvement from baseline in Global Eyelash Assessment (GEA) score and a ≥3-point improvement from baseline in total score on Domain 2 (Confidence, Attractiveness, and Professionalism) of the Eyelash Satisfaction Questionnaire (A) and for each component of the primary analysis separately (B and C). Bim=bimatoprost; veh=vehicle

Figure 2.

Responders for the composite primary analysis (both a ≥1-grade improvement from baseline in Global Eyelash Assessment (GEA) score and a ≥3-point improvement from baseline in total score on Domain 2 (Confidence, Attractiveness, and Professionalism) of the Eyelash Satisfaction Questionnaire (A) and for each component of the primary analysis separately (B and C). Bim=bimatoprost; veh=vehicle

Figure 3.

Mean change from baseline in eyelash length (A), eyelash thickness (B), and eyelash darkness (C); increased darkness is depicted by a negative change in intensity units (IU) from baseline. Bim=bimatoprost; veh=vehicle

Figure 3.

Mean change from baseline in eyelash length (A), eyelash thickness (B), and eyelash darkness (C); increased darkness is depicted by a negative change in intensity units (IU) from baseline. Bim=bimatoprost; veh=vehicle

Figure 3.

Mean change from baseline in eyelash length (A), eyelash thickness (B), and eyelash darkness (C); increased darkness is depicted by a negative change in intensity units (IU) from baseline. Bim=bimatoprost; veh=vehicle

Figure 4.

Subjects treated for 12 months with bimatoprost (Bim), whose changes in eyelash length and eyelash thickness approximated the median percentage changes for the population with chemotherapy-induced eyelash hypotrichosis receiving bimatoprost during both study periods. A) Eyelash length in a subject from the Bim/Bim group at baseline (4.5mm), 6 months (36.7% increase from baseline), and 12 months (36.7% increase from baseline). Top: Baseline length = 4.5mm. Median length at baseline for Bim/Bim postchemotherapy group = 4.80mm. Middle: Month 6 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 37.84%. Bottom: Month 12 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 39.08%. B) Eyelash thickness in a subject from the Bim/Bim group at baseline (0.30 mm2), 6 months (266.7% increase from baseline), and 12 months (200.0% increase from baseline). Top: Baseline thickness = 0.30mm2. Median thickness at baseline for Bim/Bim postchemotherapy group = 0.3 mm2. Middle: Month 6 percent increase from baseline thickness = 266.7%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 245.0%. Bottom: Month 12 percent increase from baseline thickness = 200.0%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 211.8%.

Figure 4.

Subjects treated for 12 months with bimatoprost (Bim), whose changes in eyelash length and eyelash thickness approximated the median percentage changes for the population with chemotherapy-induced eyelash hypotrichosis receiving bimatoprost during both study periods. A) Eyelash length in a subject from the Bim/Bim group at baseline (4.5mm), 6 months (36.7% increase from baseline), and 12 months (36.7% increase from baseline). Top: Baseline length = 4.5mm. Median length at baseline for Bim/Bim postchemotherapy group = 4.80mm. Middle: Month 6 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 37.84%. Bottom: Month 12 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 39.08%. B) Eyelash thickness in a subject from the Bim/Bim group at baseline (0.30 mm2), 6 months (266.7% increase from baseline), and 12 months (200.0% increase from baseline). Top: Baseline thickness = 0.30mm2. Median thickness at baseline for Bim/Bim postchemotherapy group = 0.3 mm2. Middle: Month 6 percent increase from baseline thickness = 266.7%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 245.0%. Bottom: Month 12 percent increase from baseline thickness = 200.0%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 211.8%.

Figure 4.

Subjects treated for 12 months with bimatoprost (Bim), whose changes in eyelash length and eyelash thickness approximated the median percentage changes for the population with chemotherapy-induced eyelash hypotrichosis receiving bimatoprost during both study periods. A) Eyelash length in a subject from the Bim/Bim group at baseline (4.5mm), 6 months (36.7% increase from baseline), and 12 months (36.7% increase from baseline). Top: Baseline length = 4.5mm. Median length at baseline for Bim/Bim postchemotherapy group = 4.80mm. Middle: Month 6 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 37.84%. Bottom: Month 12 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 39.08%. B) Eyelash thickness in a subject from the Bim/Bim group at baseline (0.30 mm2), 6 months (266.7% increase from baseline), and 12 months (200.0% increase from baseline). Top: Baseline thickness = 0.30mm2. Median thickness at baseline for Bim/Bim postchemotherapy group = 0.3 mm2. Middle: Month 6 percent increase from baseline thickness = 266.7%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 245.0%. Bottom: Month 12 percent increase from baseline thickness = 200.0%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 211.8%.

Figure 4.

Subjects treated for 12 months with bimatoprost (Bim), whose changes in eyelash length and eyelash thickness approximated the median percentage changes for the population with chemotherapy-induced eyelash hypotrichosis receiving bimatoprost during both study periods. A) Eyelash length in a subject from the Bim/Bim group at baseline (4.5mm), 6 months (36.7% increase from baseline), and 12 months (36.7% increase from baseline). Top: Baseline length = 4.5mm. Median length at baseline for Bim/Bim postchemotherapy group = 4.80mm. Middle: Month 6 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 37.84%. Bottom: Month 12 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 39.08%. B) Eyelash thickness in a subject from the Bim/Bim group at baseline (0.30 mm2), 6 months (266.7% increase from baseline), and 12 months (200.0% increase from baseline). Top: Baseline thickness = 0.30mm2. Median thickness at baseline for Bim/Bim postchemotherapy group = 0.3 mm2. Middle: Month 6 percent increase from baseline thickness = 266.7%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 245.0%. Bottom: Month 12 percent increase from baseline thickness = 200.0%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 211.8%.

Figure 4.

Subjects treated for 12 months with bimatoprost (Bim), whose changes in eyelash length and eyelash thickness approximated the median percentage changes for the population with chemotherapy-induced eyelash hypotrichosis receiving bimatoprost during both study periods. A) Eyelash length in a subject from the Bim/Bim group at baseline (4.5mm), 6 months (36.7% increase from baseline), and 12 months (36.7% increase from baseline). Top: Baseline length = 4.5mm. Median length at baseline for Bim/Bim postchemotherapy group = 4.80mm. Middle: Month 6 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 37.84%. Bottom: Month 12 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 39.08%. B) Eyelash thickness in a subject from the Bim/Bim group at baseline (0.30 mm2), 6 months (266.7% increase from baseline), and 12 months (200.0% increase from baseline). Top: Baseline thickness = 0.30mm2. Median thickness at baseline for Bim/Bim postchemotherapy group = 0.3 mm2. Middle: Month 6 percent increase from baseline thickness = 266.7%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 245.0%. Bottom: Month 12 percent increase from baseline thickness = 200.0%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 211.8%.

Figure 4.

Subjects treated for 12 months with bimatoprost (Bim), whose changes in eyelash length and eyelash thickness approximated the median percentage changes for the population with chemotherapy-induced eyelash hypotrichosis receiving bimatoprost during both study periods. A) Eyelash length in a subject from the Bim/Bim group at baseline (4.5mm), 6 months (36.7% increase from baseline), and 12 months (36.7% increase from baseline). Top: Baseline length = 4.5mm. Median length at baseline for Bim/Bim postchemotherapy group = 4.80mm. Middle: Month 6 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 37.84%. Bottom: Month 12 percent increase from baseline length = 36.67%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 39.08%. B) Eyelash thickness in a subject from the Bim/Bim group at baseline (0.30 mm2), 6 months (266.7% increase from baseline), and 12 months (200.0% increase from baseline). Top: Baseline thickness = 0.30mm2. Median thickness at baseline for Bim/Bim postchemotherapy group = 0.3 mm2. Middle: Month 6 percent increase from baseline thickness = 266.7%. Median percent change from baseline to Month 6 for Bim/Bim postchemotherapy group = 245.0%. Bottom: Month 12 percent increase from baseline thickness = 200.0%. Median percent change from baseline to Month 12 for Bim/Bim postchemotherapy group = 211.8%.

Figure 5.

Mean change from baseline in Eyelash Satisfaction Questionnaire Domain 2 (Confidence, Attractiveness, and Professionalism) over time. Bim=bimatoprost; veh=vehicle