Trial · NCT04806503

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.

NCT04806503, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2023-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. Trials, record NCT04806503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04806503

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
NCT number: NCT04806503
Status: Terminated
Phases: Phase 2
Enrollment: 234 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Presbyopia
Interventions: UNR844, Placebo
First posted: 2021-03-19
Last updated: 2024-06-20
Results first posted: 2023-08-30

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
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	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.
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	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.
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	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.
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	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	Baseline, Month 3	Full Analysis Set	logMAR	LEAST_SQUARES_MEAN
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	Baseline, Month 3	Full Analysis Set	logMAR	LEAST_SQUARES_MEAN
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	Baseline, Month 3	Full Analysis Set	logMAR	LEAST_SQUARES_MEAN
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	Baseline, Month 3	Full Analysis Set	Percentage of participants	NUMBER
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	Baseline, Month 3	Full Analysis Set	Percentage of participants	NUMBER
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	Baseline, Month 3	Full Analysis Set	Percentage of participants	NUMBER
POST_HOC	All Collected Deaths	On-treatment: up to 121 days, approx. 4 months. Off treatment: up to approx. 1 year and 1 month	Safety Set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	UNR844 5 mg/mL	-0.106	Standard Error 0.0186	logMAR
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	UNR844 13.3 mg/mL	-0.110	Standard Error 0.0188	logMAR
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	UNR844 23 mg/mL	-0.136	Standard Error 0.0203	logMAR
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	UNR844 30 mg/mL	-0.101	Standard Error 0.0185	logMAR
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	Placebo Ophthalmic Solution	-0.112	Standard Error 0.0194	logMAR
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	UNR844 5 mg/mL	-0.125	Standard Error 0.0217	logMAR
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	UNR844 13.3 mg/mL	-0.121	Standard Error 0.0220	logMAR
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	UNR844 23 mg/mL	-0.143	Standard Error 0.0241	logMAR
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	UNR844 30 mg/mL	-0.112	Standard Error 0.0216	logMAR
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	Placebo Ophthalmic Solution	-0.146	Standard Error 0.0228	logMAR

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	UNR844 5 mg/mL	48
Overall Study	STARTED	UNR844 13.3 mg/mL	48
Overall Study	STARTED	UNR844 23 mg/mL	44
Overall Study	STARTED	UNR844 30 mg/mL	48
Overall Study	STARTED	Placebo Ophthalmic Solution	46
Overall Study	COMPLETED	UNR844 5 mg/mL	46
Overall Study	COMPLETED	UNR844 13.3 mg/mL	47
Overall Study	COMPLETED	UNR844 23 mg/mL	42
Overall Study	COMPLETED	UNR844 30 mg/mL	46
Overall Study	COMPLETED	Placebo Ophthalmic Solution	45

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events750

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Iron deficiency anaemia	Blood and lymphatic system disorders	UNR844 5 mg/mL	1	48
other	Iron deficiency anaemia	Blood and lymphatic system disorders	UNR844 13.3 mg/mL	0	48
other	Iron deficiency anaemia	Blood and lymphatic system disorders	UNR844 23 mg/mL	0	44
other	Iron deficiency anaemia	Blood and lymphatic system disorders	UNR844 30 mg/mL	0	48
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Placebo	0	46
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Total	1	234
other	Lymphadenopathy	Blood and lymphatic system disorders	UNR844 5 mg/mL	0	48
other	Lymphadenopathy	Blood and lymphatic system disorders	UNR844 13.3 mg/mL	1	48
other	Lymphadenopathy	Blood and lymphatic system disorders	UNR844 23 mg/mL	0	44
other	Lymphadenopathy	Blood and lymphatic system disorders	UNR844 30 mg/mL	0	48

1 to 10 of 750Source ClinicalTrials.gov

See all 750 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	UNR844 5 mg/mL	0	48
Total, all-cause mortality	UNR844 13.3 mg/mL	0	48
Total, all-cause mortality	UNR844 23 mg/mL	0	44
Total, all-cause mortality	UNR844 30 mg/mL	0	48
Total, all-cause mortality	Placebo	1	46
Total, all-cause mortality	Total	1	234
Total, other adverse events	UNR844 5 mg/mL	26	48
Total, other adverse events	UNR844 13.3 mg/mL	22	48
Total, other adverse events	UNR844 23 mg/mL	16	44
Total, other adverse events	UNR844 30 mg/mL	23	48

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04806503

GET https://conductscience.org/api/trials/v1/NCT04806503/results?page=2

API reference For AI assistants