A Phase 3 interventional study of RVL-1201 and Vehicle ophthalmic solution in Blepharoptosis, sponsored by RVL Pharmaceuticals, Inc.. Completed at 36 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by RVL Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
58 studies on the registry are indexed under Blepharoptosis; 16 are open to participants now.
This study's enrollment of 164 is above the median of 46 across 47 interventional studies indexed under Blepharoptosis.
Browse Blepharoptosis studies →RVL Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
Drug: RVL-1201
Vehicle placebo ophthalmic solution
Other: Vehicle ophthalmic solution
RVL-1201 ophthalmic solution 0.1%
Vehicle placebo ophthalmic solution
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).
Time frame: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend.
Time frame: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
Planned sample size was approximately 156 subjects, 104 subjects in the RVL-1201 group, and 52 in the Vehicle group, to be enrolled at approximately 30 clinical sites in the U.S.
| Milestone | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution |
|---|---|---|
| Started | 109 | 55 |
| Completed | 108 | 53 |
| Not completed | 1 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).
| Points seen | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution |
|---|---|---|
| Mean change from baseline LPFT-Day 1 Hour 6 | 6.3 ± 6.72 | 2.1 ± 4.28 |
| Mean change from baseline LPFT-Day 14 Hour 2 | 7.7 ± 6.41 | 2.4 ± 5.26 |
The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend.
| Millimeters (mm) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution |
|---|---|---|
| Day 1, Minute 5 | 0.59 ± 0.721 | 0.20 ± 0.571 |
| Day 1, Minute 15 | 0.93 ± 0.811 | 0.32 ± 0.641 |
| Day 1, Hour 2 | 1.05 ± 0.903 | 0.33 ± 0.555 |
| Day 1, Hour 6 | 0.98 ± 0.867 | 0.35 ± 0.567 |
| Day 14, Minute 5 | 0.77 ± 0.853 | 0.42 ± 0.775 |
| Day 14, Minute 15 | 1.11 ± 0.922 | 0.41 ± 0.833 |
| Day 14, Hour 2 | 1.22 ± 0.926 | 0.43 ± 0.734 |
| Day 14, Hour 6 | 1.06 ± 0.902 | 0.47 ± 0.737 |
| Day 42, Minute 5 | 0.86 ± 0.849 | 0.42 ± 0.799 |
| Day 42, Minute 15 | 1.04 ± 0.912 | 0.47 ± 0.926 |
Collected over Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (end of study).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RVL-1201 Ophthalmic Solution, 0.1% | 0/109 (0%) | 1/109 (0.9%) | 13/109 (11.9%) |
| Vehicle Ophthalmic Solution | 0/55 (0%) | 1/55 (1.8%) | 8/55 (14.5%) |
| Event | RVL-1201 Ophthalmic Solution, 0.1% | Vehicle Ophthalmic Solution |
|---|---|---|
| Lower gastrointestinal haemorrhageGastrointestinal disorders | 0/109 | 1/55 |
| Cerebrovascular accidentNervous system disorders | 1/109 | 0/55 |
| Event | RVL-1201 Ophthalmic Solution, 0.1% | Vehicle Ophthalmic Solution |
|---|---|---|
| Conjunctival hyperaemiaEye disorders | 6/109 | 1/55 |
| Vital dye straining cornea presentInvestigations | 1/109 | 3/55 |
| Punctate keratitisEye disorders | 4/109 | 1/55 |
| Eye pruritusEye disorders | 0/109 | 2/55 |
| Instillation site complicationGeneral disorders | 0/109 | 2/55 |
| Eye painEye disorders | 3/109 | 0/55 |
Intent to Treat (ITT) Population
| Age, Categorical(Participants) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 46 | 22 | 68 |
| >=65 years | 63 | 32 | 95 |
| Age, Continuous(years) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Mean | 63.6 ± 14.31 | 63.3 ± 16.51 | 63.5 ± 15.03 |
| Age, Customized(years) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Median | 67.0 (20 to 92) | 67.0 (14 to 85) | 67.0 (14 to 92) |
| Sex: Female, Male(Participants) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Female | 77 | 39 | 116 |
| Male | 32 | 16 | 48 |
| Ethnicity (NIH/OMB)(Participants) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 6 | 19 |
| Not Hispanic or Latino | 96 | 49 | 145 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 9 |
| White | 99 | 50 | 149 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| United States | 109 | 55 | 164 |
| Iris Color OD (right eye)(Participants) | RVL-1201 Ophthalmic Solution 0.1% | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| OD-Blue | 40 | 18 | 58 |
| OD-Brown | 46 | 18 | 64 |
| OD-Green | 7 | 3 | 10 |
| OD-Hazel | 15 | 15 | 30 |
| OD-Grey | 1 | 1 | 2 |
1 further baseline measures are reported on the registry.
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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RVL Pharmaceuticals, Inc.