PresbyopiaPhase 2NCT03885011

A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia

A Phase 2 study testing CSF-1, CSF-1 Component #1 and CSF-1 Component #2 in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia. Read more about this study

Who is it for?: Ages 45 to 64 years
Conditions the study is for: Presbyopia
What is being tested?: CSF-1, CSF-1 Component #1 and CSF-1 Component #2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 7 sitesUnited States
Study dates: 26 Feb 2019to 26 Jul 2019
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects must:
Have presbyopia

Who cannot join

Subjects must not:
Have any contraindications to the study medications or diagnoses that would confound the study data

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Orasis Investigative Site
Andover, Massachusetts, 01810
Orasis Investigative Site
Bloomington, Minnesota, 55420
Orasis Investigative Site
Cranberry Township, Pennsylvania, 16066
Orasis Investigative Site
Draper, Utah, 84020
Orasis Investigative Site
Littleton, Colorado, 80120
Orasis Investigative Site
Memphis, Tennessee, 38119
Orasis Investigative Site
Newport Beach, California, 92660

Other trials in United States

About this study

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.

Read the detailed description

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia. Approximately 150 subjects will be enrolled across 7 study centers in the United States. At Visit 2, subjects will be randomized 1:1:1 to one of three treatment arms: CSF-1, CSF-1 Component #1, or CSF-1 Component #2. All subjects will dose twice a day in both eyes with a single drop of their assigned treatment for approximately 1 week. At Visit 3, subjects randomized to CSF-1 will now receive a different concentration of CSF-1, subjects randomized to CSF-1 Component #1 will receive a different concentration of CSF-1 Component #1 and subjects randomized to CSF-1 Component #2 will continue dosing with the same concentration of CSF-1 Component #2. All subjects will continue dosing twice a day in both eyes for approximately 1 week.

Conditions: Presbyopia
Being tested: CSF-1, CSF-1 Component #1, CSF-1 Component #2
Medical subject headings: Presbyopia

What participants receive

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

CSF-1Drug
This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
CSF-1 Component #1Drug
This treatment arm consists of 2 different concentrations of CSF-1 Component #1.
Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
CSF-1 Component #2Drug
This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.

Study groups in NCT03885011
Study group	Role	What they receive
CSF-1	Experimental	This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week. Receives: Drug: CSF-1
CSF-1 Component #1	Active comparator	This treatment arm consists of 2 different concentrations of CSF-1 Component #1. Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week. Receives: Drug: CSF-1 Component #1
CSF-1 Component #2	Active comparator	This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week. Receives: Drug: CSF-1 Component #2

What is being measured

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

Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Measured: 1 hour post dose on day 8
Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm)
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone
Measured: 1 hour post dose on day 15

Secondary outcomes (2)

Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm0 at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Measured: 1 hour post dose on day 8
Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone
Measured: 1 hour post dose on day 15

Timeline

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

26 Feb 201926 Jul 2019

First posted21 Mar 2019
Study start26 Feb 2019
Primary completion11 Jul 2019
Study completion26 Jul 2019

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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03885011
Sponsor's protocol ID: 18-150-0006
Status last verified: Sep 2022
First submitted: 19 Mar 2019
Last updated: 26 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
ClinicalTrials.gov ID: NCT03885011
Acronym / sponsor ID: 18-150-0006
Conditions: Presbyopia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Orasis Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 26 Feb 2019 (actual)
Primary completion: 11 Jul 2019 (actual)
Study completion: 26 Jul 2019 (actual)
First posted: 21 Mar 2019 (actual)
Results: Posted 26 Jan 2023

Clinical summary

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

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
CSF-1	Experimental	Drug: CSF-1This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
CSF-1 Component #1	Active comparator	Drug: CSF-1 Component #1This treatment arm consists of 2 different concentrations of CSF-1 Component #1. Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
CSF-1 Component #2	Active comparator	Drug: CSF-1 Component #2This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.

Who may qualify

Ages: 45 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Subjects must:

Key exclusion criteria (2 listed)

Subjects must not:

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
CSF-1This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.	Drug	CSF-1
CSF-1 Component #1This treatment arm consists of 2 different concentrations of CSF-1 Component #1. Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.	Drug	CSF-1 Component #1
CSF-1 Component #2This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.	Drug	CSF-1 Component #2

Primary outcome

Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)
Time frame: 1 hour post dose on day 8
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm)
Time frame: 1 hour post dose on day 15
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone

2 secondary outcomes

Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
Time frame: 1 hour post dose on day 8
Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
Time frame: 1 hour post dose on day 15

Results and safety

Results posted to the registry on 26 Jan 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
CSF-1-FDC	53	52
Pilo	55	52
Diclo	58	57

Primary outcome: Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)

Time frame: 1 hour post dose on day 8. Count of participants. Unit: Participants

Measure	CSF-1-FDC n = 51	Pilo n = 50	Diclo n = 56
Value	10	12	10

CSF-1-FDC vs Diclo: Odds Ratio (OR): 1.103 (95% CI 0.413 to 2.949), p = 0.8445, Regression, Logistic
Pilo vs Diclo: Odds Ratio (OR): 1.646 (95% CI 0.684 to 3.958), p = 0.2660, Regression, Logistic

Population analysed: The primary analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participant flow.

Primary outcome: Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm)

Time frame: 1 hour post dose on day 15. Count of participants. Unit: Participants

Measure	CSF-1-FDC n = 51	Pilo n = 49	Diclo n = 56
Value	22	23	9

CSF-1-FDC vs Diclo: Odds Ratio (OR): 3.664 (95% CI 1.646 to 8.154), p = 0.0015, Regression, Logistic
Pilo vs Diclo: Odds Ratio (OR): 4.745 (95% CI 2.088 to 10.786), p = 0.0002, Regression, Logistic

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 2 weeks duration of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CSF-1-FDC	0 of 53 (0%)	10 of 53 (18.9%)	0 of 53
Pilo	1 of 55 (1.8%)	13 of 55 (23.6%)	1 of 55
Diclo	0 of 58 (0%)	6 of 58 (10.3%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CSF-1, CSF-1 Component #1 and CSF-1 Component #2 in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 7 sites in United States.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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. 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 26 Jan 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?

Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) (time frame: 1 hour post dose on day 8). The study lists 2 primary outcomes in all. 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 NCT03885011.

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 26 Jan 2023.