Trial Outcomes & Findings for RHA® Redensity Eye Versus No-treatment for the Infra-Orbital Hollows (NCT NCT04577898)
NCT ID: NCT04577898
Last Updated: 2026-01-26
Results Overview
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe). Change = (Week 12 - Baseline score). A TIOHS change of 1-grade will be considered clinically significant. Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
Period 1 - Phase 1a: Week 12 after last treatment
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
RHA Redensity Eye Group
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
Pooled Safety Assessment: All Participants
Phases 1a, 1b and 2 Pooled data (i.e., after the No-Treatment group received RHA® Redensity Eye after primary endpoint at Week 12, data from both treatment groups were pooled) were used to assess the overall safety of RHA® Redensity Eye as well as effectiveness of RHA® Redensity Eye over time up to 52 weeks after treatment and 12 weeks following retreatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|---|
|
Period 1: Phase 1a
STARTED
|
183
|
65
|
0
|
|
Period 1: Phase 1a
ITT Population
|
183
|
65
|
0
|
|
Period 1: Phase 1a
PP Population
|
167
|
51
|
0
|
|
Period 1: Phase 1a
COMPLETED
|
173
|
52
|
0
|
|
Period 1: Phase 1a
NOT COMPLETED
|
10
|
13
|
0
|
|
Period 2: Phase 1b
STARTED
|
0
|
50
|
0
|
|
Period 2: Phase 1b
SAFT - ITT Population
|
0
|
50
|
0
|
|
Period 2: Phase 1b
PP Population
|
0
|
50
|
0
|
|
Period 2: Phase 1b
COMPLETED
|
0
|
48
|
0
|
|
Period 2: Phase 1b
NOT COMPLETED
|
0
|
2
|
0
|
|
Period 3: Phase 2
STARTED
|
0
|
0
|
233
|
|
Period 3: Phase 2
SAFT - ITT Population
|
0
|
0
|
233
|
|
Period 3: Phase 2
PP Population
|
0
|
0
|
217
|
|
Period 3: Phase 2
COMPLETED
|
0
|
0
|
203
|
|
Period 3: Phase 2
NOT COMPLETED
|
0
|
0
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RHA® Redensity Eye Versus No-treatment for the Infra-Orbital Hollows
Baseline characteristics by cohort
| Measure |
RHA Redensity Eye Group
n=183 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
n=65 Participants
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 10.65 • n=41 Participants
|
48.2 years
STANDARD_DEVIATION 11.11 • n=1581 Participants
|
49.5 years
STANDARD_DEVIATION 10.78 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=41 Participants
|
60 Participants
n=1581 Participants
|
220 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
28 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=41 Participants
|
58 Participants
n=1581 Participants
|
209 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=41 Participants
|
65 participants
n=1581 Participants
|
248 participants
n=4626 Participants
|
|
Fitzpatrick Skin Type
Type I-III
|
119 Participants
n=41 Participants
|
42 Participants
n=1581 Participants
|
161 Participants
n=4626 Participants
|
|
Fitzpatrick Skin Type
Type IV-VI
|
64 Participants
n=41 Participants
|
23 Participants
n=1581 Participants
|
87 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Period 1 - Phase 1a: Week 12 after last treatmentPopulation: Period 1: Phase 1a - Primary endpoint on the ITT population
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe). Change = (Week 12 - Baseline score). A TIOHS change of 1-grade will be considered clinically significant. Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=183 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
n=65 Participants
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
|
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment, Using the TIOHS - Phase 1a
|
79 percentage of responders
|
9 percentage of responders
|
PRIMARY outcome
Timeframe: Period 1 - Phase 1a: Change from Baseline at Week 12 after last treatmentPopulation: Period 1 -ITT Population
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The modified FACE-Q questionnaire is composed of 4 questions with a score linked to answers (1 being "Not at all" and 4 being "Extremely"). To calculate the FACE-Q score, outcomes from all 4 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=183 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
n=65 Participants
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
|
The Modified FACE-Q "Appearance of Lower Eyelids" Change From Baseline Score for Subjects Treated With RHA® Redensity at Week 12 After Last Treatment - Phase 1a
|
37.5 score on a scale
Standard Deviation 27.04
|
-4.1 score on a scale
Standard Deviation 17.48
|
SECONDARY outcome
Timeframe: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.Population: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. Phase 3 - Phase 2: Subjects from No-Treatment group receive their treatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=233 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
|
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after last treatment
|
197 Participants
|
—
|
|
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 24 after last treatment
|
176 Participants
|
—
|
|
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 52 after last treatment
|
135 Participants
|
—
|
|
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after retreatment
|
89 Participants
|
—
|
SECONDARY outcome
Timeframe: Period 3 - Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.Population: Period 3 -Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=233 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
|
Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after last treatment
|
205 Participants
|
—
|
|
Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 24 after last treatment
|
187 Participants
|
—
|
|
Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 52 after last treatment
|
152 Participants
|
—
|
|
Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after retreatment
|
90 Participants
|
—
|
SECONDARY outcome
Timeframe: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.Population: Period 3 - Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=233 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after last treatment
|
174 Participants
|
—
|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 24 after last treatment
|
154 Participants
|
—
|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 52 after last treatment
|
133 Participants
|
—
|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after retreatment
|
83 Participants
|
—
|
SECONDARY outcome
Timeframe: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.Population: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe). Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=233 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
|
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2
Week 12 after last treatment
|
173 Participants
|
—
|
|
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2
Week 24 after last treatment
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159 Participants
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Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2
Week 52 after last treatment
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124 Participants
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Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2
Week 12 after retreatment
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79 Participants
|
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SECONDARY outcome
Timeframe: Period 3: Phase 2 - ITT population - Change from Baseline at Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.Population: Period 3:Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 7 questions with a score linked to answers (1 being "Not at all" and 4 being "Extremely"). To calculate the FACE-Q score, outcomes from all 7 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Outcome measures
| Measure |
RHA Redensity Eye Group
n=233 Participants
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
|---|---|---|
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Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after last treatment
|
26.6 score on a scale
Standard Deviation 24.77
|
—
|
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Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 24 after last treatment
|
23.2 score on a scale
Standard Deviation 24.09
|
—
|
|
Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 52 after last treatment
|
15.1 score on a scale
Standard Deviation 23.97
|
—
|
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Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2
Week 12 after retreatment
|
30.7 score on a scale
Standard Deviation 25.52
|
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|
Adverse Events
RHA Redensity Eye Group
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pooled Safety Assessment
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RHA Redensity Eye Group
n=183 participants at risk
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
n=65 participants at risk
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
Pooled Safety Assessment
n=233 participants at risk
Phases 1a, 1b and 2 Pooled data (i.e., after the No-Treatment group received RHA® Redensity Eye after primary endpoint at Week 12, data from both treatment groups were pooled) were used to assess the overall safety of RHA® Redensity Eye as well as effectiveness of RHA® Redensity Eye over time up to 52 weeks after treatment and 12 weeks following retreatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
For the pooled population, of the 65 subjects in the No-Treatment group, 13 did not reach Week 12 to crossover and receive RHA Redensity® Eye Lido treatment and 2 of the 50 who reached Week 12 did not receive treatment at that visit. Therefore, there were 233 subjects as part of SAFT for the pooled data set
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/183 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/65 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.43%
1/233 • Number of events 1 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/183 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/65 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.43%
1/233 • Number of events 1 • 52 to 64 (for patients receiving re-treatment) weeks
|
Other adverse events
| Measure |
RHA Redensity Eye Group
n=183 participants at risk
Phase 1a RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
n=65 participants at risk
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
|
Pooled Safety Assessment
n=233 participants at risk
Phases 1a, 1b and 2 Pooled data (i.e., after the No-Treatment group received RHA® Redensity Eye after primary endpoint at Week 12, data from both treatment groups were pooled) were used to assess the overall safety of RHA® Redensity Eye as well as effectiveness of RHA® Redensity Eye over time up to 52 weeks after treatment and 12 weeks following retreatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
RHA® Redensity Eye: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
For the pooled population, of the 65 subjects in the No-Treatment group, 13 did not reach Week 12 to crossover and receive RHA Redensity® Eye Lido treatment and 2 of the 50 who reached Week 12 did not receive treatment at that visit. Therefore, there were 233 subjects as part of SAFT for the pooled data set
|
|---|---|---|---|
|
General disorders
Injection Site Discolouration
|
5.5%
10/183 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/65 • 52 to 64 (for patients receiving re-treatment) weeks
|
5.2%
12/233 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
General disorders
Injection Site Mass
|
3.3%
6/183 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/65 • 52 to 64 (for patients receiving re-treatment) weeks
|
3.9%
9/233 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
General disorders
Injection Site Swelling
|
1.6%
3/183 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/65 • 52 to 64 (for patients receiving re-treatment) weeks
|
3.9%
9/233 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Nervous system disorders
Headache
|
6.6%
12/183 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/65 • 52 to 64 (for patients receiving re-treatment) weeks
|
7.7%
18/233 • 52 to 64 (for patients receiving re-treatment) weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60