PresbyopiaPhase 2READERNCT04806503

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

A Phase 2 study testing UNR844 in people with Presbyopia, run by Novartis Pharmaceuticals at 20 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Study of safety and efficacy of UNR844 in subjects with presbyopia. Read more about this study

Who is it for?: Ages 45 to 55 years
Conditions the study is for: Presbyopia
What is being tested?: UNR844
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 234 participants
Where: 20 sitesin 4 countries
Study dates: 30 Jun 2021to 14 Oct 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 4 countries.

Country

City, postcode or hospital

20 sites in 4 countries

United States12 sites

Novartis Investigative Site
Kingston, Pennsylvania, 18704
Novartis Investigative Site
Laguna Hills, California, 92653
Novartis Investigative Site
Lake Villa, Illinois, 60046
Novartis Investigative Site
Largo, Florida, 33773
Novartis Investigative Site
Memphis, Tennessee, 38119
Novartis Investigative Site
Newport Beach, California, 92660
Novartis Investigative Site
Newport Beach, California, 92663
Novartis Investigative Site
Pittsburg, Kansas, 66762
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Sioux Falls, South Dakota, 57108
Novartis Investigative Site
Smyrna, Tennessee, 37167
Novartis Investigative Site
Washington, Missouri, 63090

Other trials in United States

Canada4 sites

Novartis Investigative Site
Kitchener, Ontario, N2A 0K5
Novartis Investigative Site
Québec, Quebec, G1S 4L8
Novartis Investigative Site
Vancouver, British Columbia, V6H 1H6
Novartis Investigative Site
Waterloo, Ontario, N2L3G1

Other trials in Canada

Australia2 sites

Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Sydney, New South Wales, 2052

Other trials in Australia

Japan2 sites

Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008
Novartis Investigative Site
Suita, Osaka, 565-0853

Other trials in Japan

About this study

Official title: A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia

Study of safety and efficacy of UNR844 in subjects with presbyopia.

Read the 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.

Conditions: Presbyopia
Being tested: UNR844, Placebo
Keywords: loss of elasticity in lens, lens, lens disorder, loss of near vision, Presbyopia, UNR844, farsightedness
Medical subject headings: Presbyopia, Lens Diseases, Hyperopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UNR844Drug
Also called EV06
Ophthalmic solution for topical ocular administration
PlaceboDrug
Also called Vehicle
Placebo

Study groups in NCT04806503
Study group	Role	What they receive
UNR844 5 mg/mL	Experimental	UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months Receives: Drug: UNR844
UNR844 13.3 mg/mL	Experimental	UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months Receives: Drug: UNR844
UNR844 23 mg/mL	Experimental	UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months Receives: Drug: UNR844
UNR844 30 mg/mL	Experimental	UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months Receives: Drug: UNR844
Placebo Ophthalmic Solution	Placebo comparator	placebo ophthalmic solution; one drop twice-a-day for three months Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Month 3

Secondary outcomes (5)

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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 3
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.
Measured: Baseline, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202114 Oct 2022

First posted19 Mar 2021
Study start30 Jun 2021
Primary completion27 Jul 2022
Study completion14 Oct 2022

Why it stopped: The study was discontinued by the Sponsor because it did not achieve the primary objective.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04806503
Sponsor's protocol ID: CUNR844A2202
Acronym: READER
Status last verified: Jun 2024
First submitted: 16 Mar 2021
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
ClinicalTrials.gov ID: NCT04806503
Acronym / sponsor ID: READER / CUNR844A2202
Conditions: Presbyopia
Keywords: loss of elasticity in lens, lens, lens disorder, loss of near vision, Presbyopia, UNR844, farsightedness
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was discontinued by the Sponsor because it did not achieve the primary objective.
Enrolment: 234 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 30 Jun 2021 (actual)
Primary completion: 27 Jul 2022 (actual)
Study completion: 14 Oct 2022 (actual)
First posted: 19 Mar 2021 (actual)
Results: Posted 30 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
UNR844 5 mg/mL	Experimental	Drug: UNR844UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844 13.3 mg/mL	Experimental	Drug: UNR844UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
UNR844 23 mg/mL	Experimental	Drug: UNR844UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844 30 mg/mL	Experimental	Drug: UNR844UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Placebo Ophthalmic Solution	Placebo comparator	Drug: Placeboplacebo ophthalmic solution; one drop twice-a-day for three months

Who may qualify

Ages: 45 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UNR844Also: EV06Ophthalmic solution for topical ocular administration	Drug	UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, UNR844 5 mg/mL
PlaceboAlso: VehiclePlacebo	Drug	Placebo Ophthalmic Solution

Primary outcome

Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Time frame: 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.

5 secondary outcomes

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
Time frame: Baseline, Month 3
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
Time frame: Baseline, Month 3
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
Time frame: Baseline, Month 3
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
Time frame: Baseline, Month 3
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
Time frame: Baseline, Month 3

Results and safety

Results posted to the registry on 30 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UNR844 5 mg/mL	48	46
UNR844 13.3 mg/mL	48	47
UNR844 23 mg/mL	44	42
UNR844 30 mg/mL	48	46
Placebo Ophthalmic Solution	46	45

Primary outcome: Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3

Time frame: Baseline, Month 3. Least squares mean (Standard Error). Unit: logMAR

Measure	UNR844 5 mg/mL n = 48	UNR844 13.3 mg/mL n = 48	UNR844 23 mg/mL n = 44	UNR844 30 mg/mL n = 48	Placebo Ophthalmic Solution n = 46
Value	-0.106 (0.0186)	-0.110 (0.0188)	-0.136 (0.0203)	-0.101 (0.0185)	-0.112 (0.0194)

UNR844 5 mg/mL vs Placebo Ophthalmic Solution: Least Squares Mean: 0.006 (95% CI -0.045 to 0.056), p = 0.817, Mixed-effect Model for Repeated Measures
UNR844 13.3 mg/mL vs Placebo Ophthalmic Solution: Least Squares Mean: 0.002 (95% CI -0.050 to 0.053), p = 0.946, Mixed-effect Model for Repeated Measures
UNR844 23 mg/mL vs Placebo Ophthalmic Solution: Least Squares Mean: -0.024 (95% CI -0.077 to 0.029), p = 0.380, Mixed-effect Model for Repeated Measures

Population analysed: Full Analysis Set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UNR844 5 mg/mL	0 of 48 (0%)	26 of 48 (54.2%)	0 of 48
UNR844 13.3 mg/mL	1 of 48 (2.1%)	22 of 48 (45.8%)	0 of 48
UNR844 23 mg/mL	0 of 44 (0%)	16 of 44 (36.4%)	0 of 44
UNR844 30 mg/mL	1 of 48 (2.1%)	23 of 48 (47.9%)	0 of 48
Placebo	3 of 46 (6.5%)	21 of 46 (45.7%)	1 of 46
Total	5 of 234 (2.1%)	108 of 234 (46.2%)	1 of 234

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Patient Lay Trial SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
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Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

20 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UNR844 in people with Presbyopia, run by Novartis Pharmaceuticals at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, Australia, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04806503.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.