A Clinical study to check the effect and safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v in patients suffering with ocular itching associated with allergic conjunctivitis.
- Conditions
- Health Condition 1: null- Ocular Itching associated with Allergic ConjunctivitisHealth Condition 2: H108- Other conjunctivitis
- Registration Number
- CTRI/2018/05/013693
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 219
1.Male or female subjects, aged 10 years to 65 years (both inclusive).
2.Treatment naïve subjects with diagnosis of ocular itching associated with allergic conjunctivitis in one or both the eyes.
3.Subjects willing to discontinue contact lens wear for at least 72 hours prior to screening visit and throughout the study.
4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures
1.Subjects with any contraindications or hypersensitivities to the use of the study medication or their components.
2.Subjects who are blind or subjects with single eye will be excluded from the study.
3.Subjects with Visual acuity of 20/80 in any eye.
4.Subjects with known case of persistent dry eye syndrome or currently on treatment for dry eyes.
5.Subjects with Vernal Keratoconjunctivitis (VKC), Atopic Keratoconjunctivitis (AKC) and Giant Papillary Conjunctivitis (GPC) will be excluded from the study.
6.Subjects with presence of ocular infection (bacterial, viral or fungal) or history of ocular herpes within 30 days of screening visit.
7.Subjects with presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
8.Subjects with chronic ocular degenerative condition or active intraocular inflammation that could worsen during the study.
9.Subjects with known case of glaucoma will be excluded from the study.
10.Subjects with known case of ocular surgery within 6 months or scheduled to undergo ocular surgery during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in ocular itching score on day 1 (Time Frame: 3, 5 and 7 minutes of post first instillation of IMP), day 2 [at 24 hrs (+1 hr) post first instillation of IMP], 7 and 14.Timepoint: At the end of Day 1, 7 and 14
- Secondary Outcome Measures
Name Time Method Change from baseline in conjunctival hyperemia grade on day 1, 7 and 14. <br/ ><br>Change from baseline in tearing score at the end of day 2,7 and 14. <br/ ><br>Change from baseline in chemosis score at the end of day 2, 7 and 14.Timepoint: At the end of Day 1, 2, 7 and 14