Presbyopia
Conditions
Keywords
loss of elasticity in lens, lens, lens disorder, loss of near vision, Presbyopia, UNR844, farsightedness
Brief summary
Study of safety and efficacy of UNR844 in subjects with presbyopia.
Detailed description
This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of: * A 1 week run-in period * A 3-month treatment course with UNR844 and/or Placebo * A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months. Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline. This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.
Interventions
DRUGUNR844
Ophthalmic solution for topical ocular administration
DRUGPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any assessment is performed * Impaired near vision in each eye and when using both eyes, without any near correction * Need a certain level of near correction
Exclusion criteria
* Impaired distance vision in either eye, with distance correction (if any) * Severe short- or long-sightedness * Any significant medical or clinical conditions affecting vision, the eyes or general health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | Baseline, Month 3 | Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | Baseline, Month 3 | Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision. |
| Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | Baseline, Month 3 | Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision. |
| Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | Baseline, Month 3 | Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision. Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines. |
| Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | Baseline, Month 3 | Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision. Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines. |
| Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | Baseline, Month 3 | Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision. Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines. |
Countries
Australia, Canada, Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UNR844 5 mg/mL UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months | 48 |
| UNR844 13.3 mg/mL UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months | 48 |
| UNR844 23 mg/mL UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months | 44 |
| UNR844 30 mg/mL UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months | 48 |
| Placebo Ophthalmic Solution placebo ophthalmic solution; one drop twice-a-day for three months | 46 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo Ophthalmic Solution | Total | UNR844 5 mg/mL | UNR844 13.3 mg/mL | UNR844 23 mg/mL | UNR844 30 mg/mL |
|---|---|---|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 2.8 | 50.9 years STANDARD_DEVIATION 2.75 | 50.8 years STANDARD_DEVIATION 2.61 | 50.9 years STANDARD_DEVIATION 2.8 | 51.0 years STANDARD_DEVIATION 2.94 | 50.5 years STANDARD_DEVIATION 2.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 52 Participants | 11 Participants | 9 Participants | 10 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 14 Participants | 4 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 166 Participants | 32 Participants | 34 Participants | 32 Participants | 34 Participants |
| Sex: Female, Male Female | 23 Participants | 135 Participants | 28 Participants | 28 Participants | 27 Participants | 29 Participants |
| Sex: Female, Male Male | 23 Participants | 99 Participants | 20 Participants | 20 Participants | 17 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 44 | 0 / 48 | 1 / 46 | 1 / 234 |
| other Total, other adverse events | 26 / 48 | 22 / 48 | 16 / 44 | 23 / 48 | 21 / 46 | 108 / 234 |
| serious Total, serious adverse events | 0 / 48 | 1 / 48 | 0 / 44 | 1 / 48 | 3 / 46 | 5 / 234 |
Outcome results
Primary
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Time frame: Baseline, Month 3
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| UNR844 5 mg/mL | Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.106 logMAR | Standard Error 0.0186 |
| UNR844 13.3 mg/mL | Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.110 logMAR | Standard Error 0.0188 |
| UNR844 23 mg/mL | Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.136 logMAR | Standard Error 0.0203 |
| UNR844 30 mg/mL | Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.101 logMAR | Standard Error 0.0185 |
| Placebo Ophthalmic Solution | Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.112 logMAR | Standard Error 0.0194 |
p-value: 0.81795% CI: [-0.045, 0.056]Mixed-effect Model for Repeated Measures
p-value: 0.94695% CI: [-0.05, 0.053]Mixed-effect Model for Repeated Measures
p-value: 0.3895% CI: [-0.077, 0.029]Mixed-effect Model for Repeated Measures
p-value: 0.66795% CI: [-0.039, 0.062]Mixed-effect Model for Repeated Measures
Secondary
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Time frame: Baseline, Month 3
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| UNR844 5 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.056 logMAR | Standard Error 0.0194 |
| UNR844 13.3 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.075 logMAR | Standard Error 0.0198 |
| UNR844 23 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.081 logMAR | Standard Error 0.021 |
| UNR844 30 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.059 logMAR | Standard Error 0.0194 |
| Placebo Ophthalmic Solution | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.085 logMAR | Standard Error 0.0206 |
p-value: 0.28495% CI: [-0.024, 0.083]Mixed-effect Model for Repeated Measures
p-value: 0.71195% CI: [-0.044, 0.065]Mixed-effect Model for Repeated Measures
p-value: 0.87195% CI: [-0.051, 0.06]Mixed-effect Model for Repeated Measures
p-value: 0.32995% CI: [-0.027, 0.08]Mixed-effect Model for Repeated Measures
Secondary
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Time frame: Baseline, Month 3
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| UNR844 5 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.125 logMAR | Standard Error 0.0217 |
| UNR844 13.3 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.121 logMAR | Standard Error 0.022 |
| UNR844 23 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.143 logMAR | Standard Error 0.0241 |
| UNR844 30 mg/mL | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.112 logMAR | Standard Error 0.0216 |
| Placebo Ophthalmic Solution | Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3 | -0.146 logMAR | Standard Error 0.0228 |
p-value: 0.47495% CI: [-0.038, 0.081]Mixed-effect Model for Repeated Measures
p-value: 0.41995% CI: [-0.036, 0.086]Mixed-effect Model for Repeated Measures
p-value: 0.91495% CI: [-0.06, 0.067]Mixed-effect Model for Repeated Measures
p-value: 0.26395% CI: [-0.026, 0.094]Mixed-effect Model for Repeated Measures
Secondary
Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision. Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Time frame: Baseline, Month 3
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UNR844 5 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 4.4 Percentage of participants |
| UNR844 13.3 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 9.3 Percentage of participants |
| UNR844 23 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 14.9 Percentage of participants |
| UNR844 30 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 5.1 Percentage of participants |
| Placebo Ophthalmic Solution | Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 4.6 Percentage of participants |
p-value: 0.51695% CI: [0.083, 10.847]Multiple Imputation, Logistic Regression
p-value: 0.17795% CI: [0.367, 16.398]Multiple Imputation, Logistic Regression
p-value: 0.07995% CI: [0.604, 22.094]Multiple Imputation, Logistic Regression
p-value: 0.47695% CI: [0.136, 8.381]Multiple Imputation, Logistic Regression
Secondary
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision. Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Time frame: Baseline, Month 3
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UNR844 5 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 6.3 Percentage of participants |
| UNR844 13.3 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 9.4 Percentage of participants |
| UNR844 23 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 0.3 Percentage of participants |
| UNR844 30 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 2.8 Percentage of participants |
| Placebo Ophthalmic Solution | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 7.8 Percentage of participants |
p-value: 0.72895% CI: [0.089, 3.593]Multiple Imputation, Logistic Regression
p-value: 0.42895% CI: [0.242, 5.529]Multiple Imputation, Logistic Regression
p-value: 0.5Multiple Imputation, Logistic Regression
p-value: 0.85195% CI: [0.026, 3.07]Multiple Imputation, Logistic Regression
Secondary
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision. Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
Time frame: Baseline, Month 3
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UNR844 5 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 13.0 Percentage of participants |
| UNR844 13.3 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 9.0 Percentage of participants |
| UNR844 23 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 8.7 Percentage of participants |
| UNR844 30 mg/mL | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 10.0 Percentage of participants |
| Placebo Ophthalmic Solution | Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3 | 11.9 Percentage of participants |
p-value: 0.57795% CI: [0.201, 3.726]Multiple Imputation, Logistic Regression
p-value: 0.80495% CI: [0.113, 2.353]Multiple Imputation, Logistic Regression
p-value: 0.8595% CI: [0.045, 2.602]Multiple Imputation, Logistic Regression
p-value: 0.68495% CI: [0.157, 3.08]Multiple Imputation, Logistic Regression
Post Hoc
All Collected Deaths
On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum timeframe of approx. 4 months. Post-treatment deaths were collected from day 31 after last dose of study medication to end of study, up to approx. 1 year and 1 month. All deaths refer to the sum of on-treatment and post-treatment deaths.
Time frame: On-treatment: up to 121 days, approx. 4 months. Off treatment: up to approx. 1 year and 1 month
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UNR844 5 mg/mL | All Collected Deaths | Total Deaths | 0 Participants |
| UNR844 5 mg/mL | All Collected Deaths | Post-Treatment Deaths | 0 Participants |
| UNR844 5 mg/mL | All Collected Deaths | On-Treatment Deaths | 0 Participants |
| UNR844 13.3 mg/mL | All Collected Deaths | On-Treatment Deaths | 0 Participants |
| UNR844 13.3 mg/mL | All Collected Deaths | Total Deaths | 0 Participants |
| UNR844 13.3 mg/mL | All Collected Deaths | Post-Treatment Deaths | 0 Participants |
| UNR844 23 mg/mL | All Collected Deaths | On-Treatment Deaths | 0 Participants |
| UNR844 23 mg/mL | All Collected Deaths | Total Deaths | 0 Participants |
| UNR844 23 mg/mL | All Collected Deaths | Post-Treatment Deaths | 0 Participants |
| UNR844 30 mg/mL | All Collected Deaths | Total Deaths | 0 Participants |
| UNR844 30 mg/mL | All Collected Deaths | Post-Treatment Deaths | 0 Participants |
| UNR844 30 mg/mL | All Collected Deaths | On-Treatment Deaths | 0 Participants |
| Placebo Ophthalmic Solution | All Collected Deaths | On-Treatment Deaths | 0 Participants |
| Placebo Ophthalmic Solution | All Collected Deaths | Total Deaths | 1 Participants |
| Placebo Ophthalmic Solution | All Collected Deaths | Post-Treatment Deaths | 1 Participants |