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ATS907 for Glaucoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Altheos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unmedicated (post-washout) IOP ≥ 23 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 18 mm Hg at 15:00-17:00 on Day 0 (Stage 1)
Unmedicated (post-washout) IOP criteria after wash out < 32 mm Hg OU at all times points (Stage 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4
Awards & highlights

Study Summary

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

Who is the study for?
Adults diagnosed with open angle glaucoma or ocular hypertension, who have specific intraocular pressure (IOP) levels after a medication washout period. They must have good corrected visual acuity and agree to stop all other ocular hypotensive medications. Excluded are those with certain types of glaucoma, recent eye surgeries, significant eye diseases, severe systemic conditions, contact lens wearers during the study, pregnant women or those not using birth control.Check my eligibility
What is being tested?
The trial is testing various doses of ATS907 against a placebo (vehicle) and latanoprost in two stages. Participants will use eye drops for up to 28 days. The first stage tests safety and tolerability; the second compares efficacy in lowering IOP. Plasma pharmacokinetics of ATS907 will also be assessed.See study design
What are the potential side effects?
Potential side effects may include local irritation at the site of application (eyes), redness, discomfort or itching in the eyes, changes in vision or eyelash growth patterns similar to other ophthalmic treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye pressure was high during my last two check-ups in the morning and one in the afternoon.
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My eye pressure is below 32 mm Hg without medication after a washout period.
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My eye pressure was high during my last two check-ups.
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My eye pressure is below 36 mm Hg without medication after a washout period.
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I am willing to stop all eye pressure medications for the study.
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I have been diagnosed with glaucoma or high eye pressure in both eyes.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in Intraocular Pressure from Baseline
Secondary outcome measures
Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP
Observed Intraocular Pressure and % change from Baseline IOP

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391
6%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Pharyngitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Acute tonsillitis
1%
Eye irritation
1%
Cataract
1%
Blepharal pigmentation
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1Experimental Treatment1 Intervention
Group II: Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1Experimental Treatment1 Intervention
Group III: Stage 1 - Arm 4 - Dose 4Experimental Treatment1 Intervention
Group IV: Stage 1 - Arm 3 - Dose 3Experimental Treatment1 Intervention
Group V: Stage 1 - Arm 2 - Dose 2Experimental Treatment1 Intervention
Group VI: Stage 1 - Arm 1 - Dose 1Experimental Treatment1 Intervention
Group VII: Stage 2 - Arm 3 -Timoptic 0.5% BIDActive Control1 Intervention
Group VIII: Stage 1 - Arm 5 - VehiclePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

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

Media Library

ATS907 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01520116 — Phase 1 & 2
Ocular Hypertension Research Study Groups: Stage 1 - Arm 4 - Dose 4, Stage 1 - Arm 2 - Dose 2, Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1, Stage 1 - Arm 1 - Dose 1, Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1, Stage 2 - Arm 3 -Timoptic 0.5% BID, Stage 1 - Arm 3 - Dose 3, Stage 1 - Arm 5 - Vehicle
Ocular Hypertension Clinical Trial 2023: ATS907 Highlights & Side Effects. Trial Name: NCT01520116 — Phase 1 & 2
ATS907 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01520116 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographical areas is this research trial being conducted?

"The current trial is in full swing at 5 different facilities, 3 of which are located in Cleveland, St. Joseph and San Antonio with the remaining two elsewhere. For convenience's sake, it may be beneficial to select a location closest to you if enrolling."

Answered by AI

What is the participant capacity of this research endeavor?

"Unfortunately, this research protocol is no longer accepting patient enrolment. The trial was introduced on January 1st 2012 and the latest changes were made October 30th 2012. Nevertheless, there are currently 940 studies for glaucoma in various stages of recruitment as well as 8 trials specifically examining ATS907 – Dose 2 that participants can sign up to join."

Answered by AI

What experiments have been conducted in association with Stage 1 - ATS907 - Dose 2 thus far?

"At the moment, 8 active clinical trials are assessing Stage 1 - ATS907 - Dose 2 with 4 of them in their concluding Phase 3. Of these ongoing studies for Stage 1 - ATS907 - Dose 2, many are situated in Campinas, São Paulo and distributed across 14 different sites."

Answered by AI

Is enrollment open for this trial at the moment?

"This medical trial is currently not accepting prospective participants. It was first published on January 1st 2012, with its last revision being made October 30th 2012. For those exploring other studies, 940 trials are actively looking for glaucoma suspects and 8 clinical studies have Stage 1 - ATS907 - Dose 2 open enrollment at the present moment."

Answered by AI

To what illnesses does Stage 1 - ATS907 - Dose 2 typically provide relief?

"ATS907 - Dose 2 from Stage 1 is regularly prescribed for individuals who did not respond to treatment with beta-blockers. Additionally, it may be used as an adjunctive or replacement therapy for open angle glaucoma (OAG), migraine prophylaxis, and other conditions."

Answered by AI
~14 spots leftby Apr 2025