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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04806503

Collaborator

(none)

235

Enrollment

Locations

Arms

21.3

Anticipated Duration (Months)

11.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: UNR844 Drug: Placebo	Phase 2

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:

Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3
Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844
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

Study Design

Study Type:

Interventional

Actual Enrollment :

235 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 30, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Apr 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Characterize dose-response of UNR844 for change from baseline in binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 [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

Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3 [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.
Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844 [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.
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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Laguna Hills	California	United States	92653
2	Novartis Investigative Site	Newport Beach	California	United States	92660
3	Novartis Investigative Site	Newport Beach	California	United States	92663
4	Novartis Investigative Site	Largo	Florida	United States	33773
5	Novartis Investigative Site	Lake Villa	Illinois	United States	60046
6	Novartis Investigative Site	Pittsburg	Kansas	United States	66762
7	Novartis Investigative Site	Washington	Missouri	United States	63090
8	Novartis Investigative Site	Kingston	Pennsylvania	United States	18704
9	Novartis Investigative Site	Sioux Falls	South Dakota	United States	57108
10	Novartis Investigative Site	Memphis	Tennessee	United States	38119
11	Novartis Investigative Site	Smyrna	Tennessee	United States	37167
12	Novartis Investigative Site	San Antonio	Texas	United States	78229
13	Novartis Investigative Site	Sydney	New South Wales	Australia	2052
14	Novartis Investigative Site	East Melbourne	Victoria	Australia	3002
15	Novartis Investigative Site	Vancouver	British Columbia	Canada	V6H 1H6
16	Novartis Investigative Site	Kitchener	Ontario	Canada	N2A 0K5
17	Novartis Investigative Site	Waterloo	Ontario	Canada	N2L3G1
18	Novartis Investigative Site	Quebec		Canada	G1S 4L8
19	Novartis Investigative Site	Suita-city	Osaka	Japan	565-0853
20	Novartis Investigative Site	Shinjuku ku	Tokyo	Japan	160-0008