Stage 1 - ATS907 - Dose 2 for Glaucoma, Suspect

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glaucoma, Suspect+4 More
Stage 1 - ATS907 - Dose 2 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the safety and effectiveness of ATS907 to latanoprost, a similar medication, in people with glaucoma or ocular hypertension.

Eligible Conditions
  • Glaucoma, Suspect
  • Glaucoma, Open-Angle

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4

Day 0
Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP
Observed Intraocular Pressure and % change from Baseline IOP
Day 14
Mean Change in Intraocular Pressure from Baseline

Trial Safety

Side Effects for

DuoTrav
6%Ocular hyperaemia
5%Eye pruritus
2%Nasopharyngitis
2%Dry eye
1%Acute tonsillitis
1%Cataract
1%Pharyngitis
1%Eye irritation
1%Eyelids pruritus
1%Ocular surface disease
1%Conjunctivitis allergic
1%Blepharal pigmentation
1%Arthritis
1%Eye pain
1%Hypersensitivity
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02003391) in the DuoTrav ARM group. Side effects include: Ocular hyperaemia with 6%, Eye pruritus with 5%, Nasopharyngitis with 2%, Dry eye with 2%, Acute tonsillitis with 1%.

Trial Design

8 Treatment Groups

Stage 2 - Arm 3 -Timoptic 0.5% BID
1 of 8
Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1
1 of 8
Stage 1 - Arm 1 - Dose 1
1 of 8
Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1
1 of 8
Stage 1 - Arm 4 - Dose 4
1 of 8
Stage 1 - Arm 3 - Dose 3
1 of 8
Stage 1 - Arm 2 - Dose 2
1 of 8
Stage 1 - Arm 5 - Vehicle
1 of 8

Active Control

Experimental Treatment

Non-Treatment Group

180 Total Participants · 8 Treatment Groups

Primary Treatment: Stage 1 - ATS907 - Dose 2 · Has Placebo Group · Phase 1 & 2

Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1
Drug
Experimental Group · 1 Intervention: Stage 2 - ATS907 - Dose B - to be selected based on Stage 1 · Intervention Types: Drug
Stage 1 - Arm 1 - Dose 1
Drug
Experimental Group · 1 Intervention: Stage 1 - ATS907 - Dose 1 · Intervention Types: Drug
Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1
Drug
Experimental Group · 1 Intervention: Stage 2 - ATS907 - Dose A - to be selected based on Stage 1 · Intervention Types: Drug
Stage 1 - Arm 4 - Dose 4
Drug
Experimental Group · 1 Intervention: Stage 1 - ATS907 - Dose 4 · Intervention Types: Drug
Stage 1 - Arm 3 - Dose 3
Drug
Experimental Group · 1 Intervention: Stage 1 - ATS907 - Dose 3 · Intervention Types: Drug
Stage 1 - Arm 2 - Dose 2
Drug
Experimental Group · 1 Intervention: Stage 1 - ATS907 - Dose 2 · Intervention Types: Drug
Stage 2 - Arm 3 -Timoptic 0.5% BID
Drug
ActiveComparator Group · 1 Intervention: Timoptic · Intervention Types: Drug
Stage 1 - Arm 5 - Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Stage 1 - Vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4

Who is running the clinical trial?

Altheos, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Barbara Wirostko, MDStudy ChairAltheos, Inc.

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who have an unmedicated (post-washout) IOP of 24 mm Hg or more at two eligibility visits on days 0 and 1, and an IOP of 21 mm Hg or more at 9:00-17:00 on day 0, are in stage 2.
The patient's unmedicated IOP is 36 mm Hg or less in both eyes at all time points after washout.
, including post-study follow-up The subject must stop using all ocular hypotensive medications in both eyes before and during the study, as well as after the study is completed.
A person's corrected visual acuity in each eye is better than 1.0 logMAR, which is equal to 20/200.
People who are 18 years of age or greater are allowed to vote in the United States.
A person who had IOPs of 23 mm Hg or more on two occasions seven hours apart on days 0 and 1 was determined to be in stage 1.
The unmedicated (post-washout) IOP criteria after washout is < 32 mm Hg OU at all times points (Stage 1).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.