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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unmedicated (post-washout) IOP criteria after wash out < 32 mm Hg OU at all times points (Stage 1)
Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 21 mm Hg at 9:00-17:00 on Day 0 (Stage 2)
Must not have
Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.)
History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4
Awards & highlights
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 belowSelect...
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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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had vision correction surgery in the eye being studied.
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I haven't had any major eye infections or inflammation in the last 3 months.
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I have a serious eye condition that affects the cornea's shape or clarity.
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I haven't changed my medication that could affect my eye pressure or blood pressure in the last week.
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I have a history of specific types of glaucoma in one or both eyes.
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I do not have any uncontrolled major illnesses like diabetes or heart disease.
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I do not have serious eye conditions that could worsen during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 1: days 0, 1, 4, 14, 21, 28; stage 2: days 0, 4
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 • NCT020033916%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Blepharal pigmentation
1%
Acute tonsillitis
1%
Pharyngitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Eye irritation
1%
Cataract
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye pressure was high during my last two check-ups in the morning and one in the afternoon.My eye pressure is below 32 mm Hg without medication after a washout period.My eye pressure was high during my last two check-ups.My eye pressure is below 36 mm Hg without medication after a washout period.I have had vision correction surgery in the eye being studied.I have not had cataract or any eye surgery in the last 3 months.I haven't had any major eye infections or inflammation in the last 3 months.I have a serious eye condition that affects the cornea's shape or clarity.I am not pregnant, nursing, or planning to become pregnant and use birth control.I have been diagnosed with glaucoma or high eye pressure in both eyes.I am willing to stop all eye pressure medications for the study.You have important problems in your blood tests when you were checked before the study.I haven't changed my medication that could affect my eye pressure or blood pressure in the last week.I have had glaucoma surgery or laser treatment in my study eye.You can see clearly with each eye at least as well as 20/200.I have a history of specific types of glaucoma in one or both eyes.I am 18 years old or older.I do not have any uncontrolled major illnesses like diabetes or heart disease.The thickness of your cornea in the eye being studied is below 480 or above 600 micrometers.I do not have serious eye conditions that could worsen during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 - Arm 4 - Dose 4
- Group 2: Stage 1 - Arm 2 - Dose 2
- Group 3: Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1
- Group 4: Stage 1 - Arm 1 - Dose 1
- Group 5: Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1
- Group 6: Stage 2 - Arm 3 -Timoptic 0.5% BID
- Group 7: Stage 1 - Arm 3 - Dose 3
- Group 8: Stage 1 - Arm 5 - Vehicle
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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