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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03533244




Registration number
NCT03533244
Ethics application status
Date submitted
27/04/2018
Date registered
23/05/2018
Date last updated
6/11/2020

Titles & IDs
Public title
A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia
Scientific title
A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium
Secondary ID [1] 0 0
P2-86893-001
Universal Trial Number (UTN)
Trial acronym
SURPH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pterygium 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 0.1% AG-86893 Eye Drops
Treatment: Drugs - 0.3% AG-86893 Eye Drops
Treatment: Drugs - Vehicle Eye Drops

Placebo comparator: Vehicle Eye Drops - One drop, three times daily to the study eye for 28 days

Experimental: 0.1% AG-86893 Eye Drops - One drop, three times daily to the study eye for 28 days

Experimental: 0.3% AG-86893 Eye Drops - One drop, three times daily to the study eye for 28 days


Treatment: Drugs: 0.1% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days

Treatment: Drugs: 0.3% AG-86893 Eye Drops
One drop, three times daily to the study eye for 28 days

Treatment: Drugs: Vehicle Eye Drops
One drop, three times daily to the study eye for 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Overall Conjunctival Hyperemia Score
Timepoint [1] 0 0
Baseline and Day 28
Secondary outcome [1] 0 0
Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium
Timepoint [1] 0 0
Baseline and Day 28

Eligibility
Key inclusion criteria
* Good health with no clinically significant findings based on the medical history, electrocardiogram, vital signs, blood chemistry, hematology, and urinalysis findings, as determined by the investigator
* Females of childbearing potential must have a negative pregnancy test at baseline and must be on established, adequate contraception and males must use condoms if their partner is of childbearing potential and their female partner should also use an additional effective means of contraception, or they must agree to abstain from sexual intercourse with a female partner for the duration of the study; contraception should be continued for 3 months after the last dose.
* Presence of pterygium with associated conjunctival hyperemia (redness) of grade =2 as assessed by a central reading center.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or presence of any ocular diseases other than pterygium or its sequelae (after-effects), including neoplasia (uncontrolled overgrowth)
* Diagnosis of ocular hypertension or glaucoma requiring use of intraocular pressure-lowering medication
* Use of contact lenses during the study in the study eye
* History or evidence of ocular surgeries in the study eye at any time
* History of liver dysfunction or current abnormal liver enzymes
* Pregnancy, plans for pregnancy, or breastfeeding during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2019
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
M.T. Coroneo Pty Ltd - Randwick
Recruitment hospital [2] 0 0
H2Vision Centre - Sippy Downs
Recruitment hospital [3] 0 0
Bendigo Eye Clinic - Bendigo
Recruitment hospital [4] 0 0
Essendon Eye Clinic - Essendon
Recruitment hospital [5] 0 0
The Geelong Eye Centre - Waurn Ponds
Recruitment hospital [6] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Sippy Downs
Recruitment postcode(s) [3] 0 0
- Bendigo
Recruitment postcode(s) [4] 0 0
- Essendon
Recruitment postcode(s) [5] 0 0
- Waurn Ponds
Recruitment postcode(s) [6] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allgenesis Biotherapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.

Hypothesis

1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle
2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle
Trial website
https://clinicaltrials.gov/study/NCT03533244
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03533244