A Human Ocular Instillation study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Ophthalmological assessment of Ocular Tolerance of the test product (i.e., degree of inflammation of bulbar and palpebral conjunctiva and lacrimation).
Study Overview
Brief Summary
This is a double blinded, randomized, single-arm clinicalstudy to determine the ocular irritation potential of the test product onhealthy adult human subjects by direct eye-instillation technique.
The study will be conducted in 2 groups:
- Group I: 18 enrolled subjects to get at-least 15completed subjects.
- Group II: 18 enrolled subjects to get at-least15 completed subjects.
Initially the study will commence with group I.Based on the interim analysis of the data of group I and EC Approval of Group Idata, group II study will commence. Both groups will follow the same procedure.
The potential subjects will be screened as perthe inclusion and exclusion criteria only after obtaining written informedconsent from the subjects. Subjects will need to meet the pre-qualification criteria (generaleye examination, visualacuity test and OphthalmologistEye evaluation) in order to be eligible to participate in the study.
Upon qualification for the study, each subjectwill receive one test product and distilled water. Thetest product and distilled water will be randomly assigned to the right andleft eye of each subject.
Once product has been applied to both eyes, theophthalmologist will evaluate the eye area and the subject will rate theirself-perceived discomfort.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy adult non-pregnant/non-lactating females with age 18 to 65 years (both inclusive) at the time of consent.
- •Subjects in general good health as determined by the Investigator on the basis of medical history and with no medical conditions of the eye.
- •Subjects who pass a general eye examination as assessed by Ophthalmologist.
- •Subjects who pass an eye sting evaluation using isotonic saline and an Ophthalmologist Eye evaluation as assessed by Ophthalmologist.
- •Subjects having visual acuity of at least 20/40 (with corrective wear, i.e., glasses but not contact lens).
Exclusion Criteria
- •Subjects wearing any facial and eye makeup including false eye lashes on the day of the study visits.
- •Subjects currently using or have used eye drops (e.g., Visine, Saline Solutions, etc.) within the last 2 weeks.
- •Subjects who ever had any eye conditions such glaucoma, cataracts, exophthalmos (protuberance of eye), etc.
- •Subjects having any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within 2 weeks of the study.
- •Subjects who had any eye surgery (including Lasik, laser eye surgery).
- •Subjects having any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
Outcomes
Primary Outcomes
Ophthalmological assessment of Ocular Tolerance of the test product (i.e., degree of inflammation of bulbar and palpebral conjunctiva and lacrimation).
Time Frame: Day 01 (30 secs, 3 mins, 5 mins, 10 mins, 15 mins and 60 mins after instillation) | Day 02 (24 hrs after instillation)
Secondary Outcomes
- Assessment of self-perceived discomfort using 4-point scale by subjects.(Day 01 (30 secs, 15 mins and 60 mins after instillation))