A study to test a drug for the treatment of pterygium
- Conditions
- Health Condition 1: H110- Pterygium of eye
- Registration Number
- CTRI/2024/01/061151
- Lead Sponsor
- Cloudbreak Therapeutics,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
The following are requirements for enrollment into the study.
1.Male or female at least 12 years of age at the time of consent.
2.Female subjects must agree to use an acceptable method of contraception.
3.Diagnostic Inclusion Criteria
• The conjunctival hyperemia grade and pterygium length will be confirmed to meet criteria by an independent reading center using digital images.
Primary or recurrent pterygium subjects: At least one eye meeting all requirements below is considered to have met this criterion:
a.At the Screening visit (Day -14 to Day -5), global conjunctival hyperemia grade in the pterygium eye = 3 on a 0 to 4-point scale, confirmed by the reading center based on the photographs captured at Screening (Day -14 to Day -5) visit.
b.If both Nasal and Temporal pterygia are present in an eye, the location with the greater hyperemia grade will be used to qualify the eye. If the Nasal and Temporal hyperemia are equally severe, the Nasal pterygium will be the location to qualify the eye.
c.A minimum of 1.2 mm and a maximum of 4.5 mm encroachment of the pterygium onto the cornea, confirmed by the reading center, based on the photographs captured at Screening (Day -14 to Day -5) visit.
d.The eye symptom score is = 2 at both Screening (Day -14 to Day -5) and Baseline (Day 1) visits.
e.For recurrent pterygium patients, pterygium excision surgery should have been performed = 6 months before Screening.
4.Subject has a visual acuity LogMAR score of 1.00 or better in at least one eye at Screening and Baseline (Day 1), using a logarithmic (LogMar) visual acuity chart.
5.Is in good general health as determined by the investigator from medical history and physical examination findings, non-fasting blood analysis (complete blood count [CBC] with differential, blood chemistry) within reference range or acceptable to the investigator prior to randomization. Note: For the screening laboratory evaluation, subjects may have laboratory tests repeated once for reassessment at the discretion of the investigator prior to randomization. The investigator must review the screening results to confirm subject qualification for study entry
Informed Consent and Written Authorization
6.Written informed assent/consent of the subject has been obtained prior to any study related procedures. If a subject is younger than the legal age of consent per local laws, the subject’s parent(s), guardian or legally authorized representative will provide written informed consent. The subject will provide age-appropriate verbal or written assent.
7.Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g., Written Authorization for Use and Release of Health and Research Study Information).
If any of the following criteria are met, the subject is not eligible for participation in the study:
1.Subject has known uncontrolled systemic disease including cancer under active treatment.
2.Active ocular infection or conjunctivitis. NOTE: subjects with mild Blepharitis not requiring antibiotic therapy are allowed.
3.Clinically significant corneal abnormalities other than pterygium or related to prior pterygium surgery that may affect the validity of the study findings.
4.History of ocular herpes disease in either eye.
5.Any retina disease that could affect visual acuity (e.g., exudative age-related macular degeneration, diabetic macular edema, etc.).
6.Any ocular surgery or procedure (except pterygium excision surgery) within the last 90 days prior to screening, including eye lid surgery, and dissolvable long-term punctal plugs in the eye(s) with pterygium. Subjects that have undergone capsulotomy in the eye(s) with pterygium will be allowed if the procedure was performed at least 30 days prior to screening.
7.Female who is pregnant, nursing, or planning a pregnancy, or female of childbearing potential not using reliable means of contraception.
8.Known allergy or sensitivity to the study medication(s) or its components.
9.Finding of pseudo-pterygium, marginal corneal disease, ocular neoplasia (e.g., carcinoma in situ, squamous cell carcinoma, other neoplastic diseases), or history of chemical or thermal ocular burn in either eye.
10.Within 30 days prior to Screening: use or anticipated chronic useof any topical ocular drugs anti-inflammatory drugs including allergy medications, steroids, NSAIDs for more than 14 days at a time and more than 3 times per year in the eye(s) with pterygium.
11.Within 30 days prior to Screening: use or anticipated use of any topical ocular medication known to cause conjunctival hyperemia (eg, prostaglandin analogues) or vasoconstriction (e.g., topical alpha-agonists) in the eye(s) with pterygium.
12.Within 90 days prior to Screening: use or anticipated use of topical ocular cyclosporine or lifitegrast.
13.Use or anticipated use of artificial tears greater than 2 times per day in the eye(s) with pterygium.
14.History or evidence of severe ocular trauma in the eye(s) with pterygium.
15.Concurrent enrollment in an investigational drug or device study or participation in such a study within 30 days prior to Screening.
16.Anticipated regular use of contact lenses in the eye(s) with pterygium during the study.
17.Anticipated pterygium surgery within a year of enrollment in the study.
18.History of severe seasonal ocular allergy.
19.Any condition or situation in the investigator’s opinion, which, after consultation with the medical monitor., may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean difference of conjunctival hyperemia grade change from baseline <br/ ><br>2.Mean difference of pterygium lesion length change from baseline <br/ ><br>3.Mean difference of subjects’ eye symptom score change from baseline <br/ ><br>Timepoint: Month 3 <br/ ><br>Month 12 <br/ ><br>Month 12
- Secondary Outcome Measures
Name Time Method 1.Mean difference of conjunctival hyperemia grade change from baselineTimepoint: Month 1 <br/ ><br>Month 12 <br/ ><br>Week 2;2.Mean difference on subjects’ eye symptom score change from baselineTimepoint: Month 6 <br/ ><br>Month 3;3.Mean difference of pterygium vascularity grade change from baselineTimepoint: Month 3 <br/ ><br>Week 2;Safety measures: <br/ ><br>•Ocular and non-ocular adverse events <br/ ><br>•Clinically significant abnormal changes compared to baseline in ocular symptoms, visual acuity, intraocular pressure, biomicroscopy, ophthalmoscopy <br/ ><br>•Clinically significant abnormal changes compared to baseline in vital signs and clinical laboratory <br/ ><br> <br/ ><br>Timepoint: NA