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.

â??A Phase III, Multicenter, Comparative, Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluate Efficacy and Safety of Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v as compared with Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v for the treatment of Ocular Itching associated with Allergic Conjunctivitis.â??

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013693

Enrollment

250

Registered

2018-05-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Ocular Itching associated with Allergic Conjunctivitis Health Condition 2: H108- Other conjunctivitis

Interventions

Intervention1: Olopatadine Hydrochloride Ophthalmic Solution 0.7% w/v: Instill one drop in each affected eye once a day for 14 days. Control Intervention1: Olopatadine Hydrochloride Ophthalmic Solutio

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects, aged 10 years to 65 years (both inclusive). 2. Treatment naÃ¯ve 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change from baseline in conjunctival hyperemia grade on day 1, 7 and 14. Change from baseline in tearing score at the end of day 2,7 and 14. 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	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Limited

shailesh.singh@ajantapharma.com2266062111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026