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History of Changes for Study: NCT04806503
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Latest version (submitted November 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 16, 2021 None (earliest Version on record)
2 March 24, 2021 Oversight and Study Status
3 June 1, 2021 Study Status
4 June 28, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 July 5, 2021 Study Status and Contacts/Locations
6 July 9, 2021 Contacts/Locations and Study Status
7 July 15, 2021 Contacts/Locations and Study Status
8 July 23, 2021 Contacts/Locations and Study Status
9 August 6, 2021 Study Status and Contacts/Locations
10 August 20, 2021 Study Status and Contacts/Locations
11 September 21, 2021 Study Status and Contacts/Locations
12 October 1, 2021 Study Status and Contacts/Locations
13 November 29, 2021 Study Status and Contacts/Locations
14 December 2, 2021 Study Status
15 December 8, 2021 Contacts/Locations and Study Status
16 January 14, 2022 Study Status
17 January 21, 2022 Contacts/Locations and Study Status
18 February 3, 2022 Study Status and Contacts/Locations
19 February 7, 2022 Contacts/Locations and Study Status
20 March 31, 2022 Study Status and Contacts/Locations
21 April 12, 2022 Study Status
22 April 29, 2022 Contacts/Locations and Study Status
23 May 6, 2022 Study Status and Contacts/Locations
24 May 9, 2022 Contacts/Locations and Study Status
25 May 12, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
26 May 16, 2022 Study Design and Study Status
27 May 20, 2022 Study Status
28 May 23, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
29 May 30, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
30 June 13, 2022 Study Status
31 September 14, 2022 Study Status
32 November 3, 2022 Recruitment Status and Study Status
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Study NCT04806503
Submitted Date:  March 16, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: CUNR844A2202
Brief Title: A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Not yet recruiting
Study Start: May 4, 2021
Primary Completion: January 18, 2022 [Anticipated]
Study Completion: September 27, 2022 [Anticipated]
First Submitted: March 16, 2021
First Submitted that
Met QC Criteria:
March 16, 2021
First Posted: March 19, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 16, 2021
Last Update Posted: March 19, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Study of safety and efficacy of UNR844 in subjects with presbyopia.
Detailed Description:

This is a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study is approximately 13 months. Approximately 225 presbyopic participants will be enrolled into the study.

Presbyopic participants aged 45 to 55 years are the primary age group in this study.

Screening and Baseline: Participants will be screened for eligibility followed by a baseline visit after which they will be randomized to receive either UNR844 (low, medium 1, medium 2, and high) or Placebo, dosed one drop in each eye twice daily, for 3 months and then will undergo a 9 month treatment holiday period.

Randomized subjects will attend the following study visits after baseline: at Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11 and Month 12.

The primary objective for the study is to characterize dose-response of UNR844 for change from baseline in binocular DCNVA at Month 3.

There are 3 secondary objectives:

  1. Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3
  2. Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844
  3. Evaluate the efficacy of improving DCNVA in presbyopic participants, as measured by proportion of participants gaining at least 0.3 logMAR DCNVA at Month 3
Open or close this module Conditions
Conditions: Presbyopia
Keywords: loss of elasticity in lens
lens
lens disorder
loss of near vision
Presbyopia
UNR844
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 5
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 225 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: UNR844 Low
UNR844 Low ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Names:
  • EV06
Experimental: UNR844 Medium 1
UNR844 Medium 1 ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Names:
  • EV06
Experimental: UNR844 Medium 2
UNR844 Medium 2 ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Names:
  • EV06
Experimental: UNR844 High
UNR844 High ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Names:
  • EV06
Placebo Comparator: Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
Drug: Placebo
Placebo
Other Names:
  • Vehicle
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Characterize dose-response of UNR844 for change from baseline in binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
[ Time Frame: Month 3 ]

Characterize dose-response of UNR844 for change from baseline in binocular DCNVA at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refractive errors. Low logMAR score represent good vision while a high logMAR score represent bad vision.
Secondary Outcome Measures:
1. Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3
[ Time Frame: Month 3 ]

Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA in logMAR, at 40 cm at Month 3. Low logMAR score represent good vision while a high logMAR score represent bad vision.
2. Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844
[ Time Frame: Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11 and Month 12 ]

Binocular and monocular DCNVA measured in logMAR, at 40 cm monthly after treatment cessation at Month3. Low logMAR score represent good vision while a high logMAR score represent bad vision.
3. Evaluate the efficacy of improving DCNVA in presbyopic participants, as measured by proportion of participants gaining at least 0.3 logMAR DCNVA at Month 3
[ Time Frame: Month 3 ]

Proportion of participants gaining at least 0.3 logMAR in binocular and monocular 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 refractive errors. Low logMAR score represent good vision while a high logMAR score represent bad vision.
Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: 1-888-669-6682
Email: novartis.email@novartis.com
Central Contact Backup: Novartis Pharmaceuticals
Telephone: +41613241111
Study Officials: Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD: 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/.

Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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