Trial Outcomes & Findings for Silicone Gel for Postsurgical Scars of the Eyelid (NCT NCT03601247)
NCT ID: NCT03601247
Last Updated: 2026-02-17
Results Overview
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.
COMPLETED
NA
132 participants
Up to 6 months post-operation
2026-02-17
Participant Flow
In this prospective, double-blinded split-face randomized study, patients who had already consented to undergoing surgical repair of upper eyelid ptosis or blepharoplasty were asked by the surgeon/principal investigator (PI) if they wished to participate in the study. The informed consent process took place in the PI's office after routine pre-operative counseling and discussion was performed for repair of upper eyelid ptosis or blepharoplasty.
Based on the "split face" study design, there were 96 participants in each arm. Each participant served as their own control and had silicone gel applied to one eye and placebo treatment applied to the other eye. There was no attrition between consent/enrollment and randomization. Attrition after randomization is summarized in the tables below.
Unit of analysis: Eyes
Participant milestones
| Measure |
Silicone Gel Eye
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Overall Study
STARTED
|
132 132
|
132 132
|
|
Overall Study
COMPLETED
|
96 96
|
96 96
|
|
Overall Study
NOT COMPLETED
|
36 36
|
36 36
|
Reasons for withdrawal
| Measure |
Silicone Gel Eye
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
36
|
36
|
Baseline Characteristics
Silicone Gel for Postsurgical Scars of the Eyelid
Baseline characteristics by cohort
| Measure |
All Study Participants
n=96 eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo (petrolatum ointment) or silicone gel.
|
|---|---|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 9.2 • n=25 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
63 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Prefer not to specify
|
10 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months post-operationTo determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.
Outcome measures
| Measure |
Silicone Gel Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Post-operative Scarring - Erythema
Week 1
|
1.67 score on a scale
Standard Deviation 0.61
|
1.70 score on a scale
Standard Deviation 0.60
|
|
Post-operative Scarring - Erythema
Month 1
|
1.50 score on a scale
Standard Deviation 0.56
|
1.65 score on a scale
Standard Deviation 0.69
|
|
Post-operative Scarring - Erythema
Month 3
|
1.32 score on a scale
Standard Deviation 0.48
|
1.37 score on a scale
Standard Deviation 0.50
|
|
Post-operative Scarring - Erythema
Month 6
|
1.00 score on a scale
Standard Deviation 0.00
|
1.09 score on a scale
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Up to 6 months post-operationTo determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (\<0.5 mm)", and "3=definite elevation (\>0.5 mm)". Higher mean scores are associated with increased elevation.
Outcome measures
| Measure |
Silicone Gel Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Post-operative Scarring - Elevation
Week 1
|
1.50 score on a scale
Standard Deviation 0.54
|
1.48 score on a scale
Standard Deviation 0.54
|
|
Post-operative Scarring - Elevation
Month 1
|
1.38 score on a scale
Standard Deviation 0.49
|
1.29 score on a scale
Standard Deviation 0.52
|
|
Post-operative Scarring - Elevation
Month 3
|
1.11 score on a scale
Standard Deviation 0.32
|
1.11 score on a scale
Standard Deviation 0.32
|
|
Post-operative Scarring - Elevation
Month 6
|
1.00 score on a scale
Standard Deviation 0.00
|
1.00 score on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 6 months post-operationTo determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively.
Outcome measures
| Measure |
Silicone Gel Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Post-operative Scarring - Pigmentation
Week 1
|
1.48 score on a scale
Standard Deviation 0.50
|
1.50 score on a scale
Standard Deviation 0.50
|
|
Post-operative Scarring - Pigmentation
Month 1
|
1.44 score on a scale
Standard Deviation 0.50
|
1.47 score on a scale
Standard Deviation 0.51
|
|
Post-operative Scarring - Pigmentation
Month 3
|
1.22 score on a scale
Standard Deviation 0.43
|
1.16 score on a scale
Standard Deviation 0.37
|
|
Post-operative Scarring - Pigmentation
Month 6
|
1.09 score on a scale
Standard Deviation 0.30
|
1.18 score on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Up to 6 months post-operationTo determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars patient satisfaction with post-operative scars was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via a questionnaire. Patients could choose between "1=very dissatisfied", "2=dissatisfied", "3=neutral", "4=satisfied", "5=very satisfied."
Outcome measures
| Measure |
Silicone Gel Eye
n=96 Participants
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 Participants
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Patient Satisfaction
Week 1
|
3.87 score on a scale
Standard Deviation 0.67
|
3.94 score on a scale
Standard Deviation 0.63
|
|
Patient Satisfaction
Month 1
|
4.00 score on a scale
Standard Deviation 0.65
|
4.00 score on a scale
Standard Deviation 0.65
|
|
Patient Satisfaction
Month 3
|
4.21 score on a scale
Standard Deviation 0.98
|
4.26 score on a scale
Standard Deviation 0.99
|
|
Patient Satisfaction
Month 6
|
4.45 score on a scale
Standard Deviation 0.52
|
4.36 score on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Up to 6 months post-operationPost-operative Itching was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medication". Higher mean scores are associated with increased itching.
Outcome measures
| Measure |
Silicone Gel Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Post-operative Itching
Month 3
|
1.21 score on a scale
Standard Deviation 0.42
|
1.26 score on a scale
Standard Deviation 0.45
|
|
Post-operative Itching
Month 6
|
1.27 score on a scale
Standard Deviation 0.47
|
1.18 score on a scale
Standard Deviation 0.40
|
|
Post-operative Itching
Week 1
|
1.69 score on a scale
Standard Deviation 0.47
|
1.72 score on a scale
Standard Deviation 0.49
|
|
Post-operative Itching
Month 1
|
1.41 score on a scale
Standard Deviation 0.50
|
1.35 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Up to 6 months post-operationPost-operative Pain was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medical attention". Higher mean scores are associated with increased pain.
Outcome measures
| Measure |
Silicone Gel Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 Eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Post-Operative Pain
Week 1
|
1.11 score on a scale
Standard Deviation 0.32
|
1.09 score on a scale
Standard Deviation 0.29
|
|
Post-Operative Pain
Month 1
|
1.09 score on a scale
Standard Deviation 0.29
|
1.06 score on a scale
Standard Deviation 0.24
|
|
Post-Operative Pain
Month 3
|
1.00 score on a scale
Standard Deviation 0.00
|
1.05 score on a scale
Standard Deviation 0.23
|
|
Post-Operative Pain
Month 6
|
1.09 score on a scale
Standard Deviation 0.30
|
1.09 score on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 6 months post-operationPopulation: The totals in the table demonstrate the number of participants who completed the Patient Scar Preference question at each timepoint.
To determine whether silicone gel treatment has any effect on patient preference of post-surgical eyelid scar treatment, patient preference with scars at 1 week, 1 month, and 6 months post-operation was assessed by a questionnaire. Blinded patients could choose "right" or "left" or "neither". Non-blinded coders then converted patient responses to "Silicone Gel treatment preferred" or "Placebo treatment preferred" or "Neither treatment preferred" based on each patient's eye randomization. The number of patients in each categorical variable is summarized by study arm.
Outcome measures
| Measure |
Silicone Gel Eye
n=54 Participants
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Patient Scar Preference
Week 1 · Silicone Gel treatment preferred
|
13 Participants
|
—
|
|
Patient Scar Preference
Week 1 · Placebo treatment preferred
|
11 Participants
|
—
|
|
Patient Scar Preference
Week 1 · Neither treatment preferred
|
30 Participants
|
—
|
|
Patient Scar Preference
Month 1 · Silicone Gel treatment preferred
|
7 Participants
|
—
|
|
Patient Scar Preference
Month 1 · Placebo treatment preferred
|
16 Participants
|
—
|
|
Patient Scar Preference
Month 1 · Neither treatment preferred
|
11 Participants
|
—
|
|
Patient Scar Preference
Month 3 · Silicone Gel treatment preferred
|
8 Participants
|
—
|
|
Patient Scar Preference
Month 3 · Placebo treatment preferred
|
6 Participants
|
—
|
|
Patient Scar Preference
Month 3 · Neither treatment preferred
|
5 Participants
|
—
|
|
Patient Scar Preference
Month 6 · Silicone Gel treatment preferred
|
4 Participants
|
—
|
|
Patient Scar Preference
Month 6 · Placebo treatment preferred
|
0 Participants
|
—
|
|
Patient Scar Preference
Month 6 · Neither treatment preferred
|
6 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 months post-operationPost-operative scar firmness was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=normal or soft/supple" and "2=hard". Higher mean scores are associated with increased firmness.
Outcome measures
| Measure |
Silicone Gel Eye
n=96 eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel.
|
Placebo Eye
n=96 eyes
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment).
|
|---|---|---|
|
Post-operative Firmness
Month 6
|
1.00 score on a scale
Standard Deviation 0.00
|
1.00 score on a scale
Standard Deviation 0.00
|
|
Post-operative Firmness
Week 1
|
1.19 score on a scale
Standard Deviation 0.52
|
1.22 score on a scale
Standard Deviation 0.60
|
|
Post-operative Firmness
Month 1
|
1.12 score on a scale
Standard Deviation 0.33
|
1.24 score on a scale
Standard Deviation 0.61
|
|
Post-operative Firmness
Month 3
|
1.16 score on a scale
Standard Deviation 0.50
|
1.11 score on a scale
Standard Deviation 0.46
|
Adverse Events
Silicone Gel Eye
Placebo Eye
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place