A clinical study to compare the safety and performance of Evolve HA preservative-free eye drops with Aquim PF preservative-free eye drops in patients with Dry Eye Disease.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Evolve HA: 1 drop per eye, four times daily will be instilled for 06 months Control Intervention1: Aquim PF: 1 drop per eye, four times daily will be instilled for 06 months CONDITION: Health Condition 1: H048‐ Other disorders of lacrimal system PRIMARY OUTCOME: Change from baseline in Tear Break Up Time scoreTimepoint: Baseline, 1 Month,3 months and 6 months SECONDARY OUTCOME: Change from baseline in corneal fluorescein staining score using Oxford scaleTimepoint: Baseline,1 Month, 3 Months, and 6 Months. Change from baseline in Ocular Surface Disease Inde X; Timepoint: Baseline,1 Month, 3 Months, and 6 Months. INCLUSION CRITERIA: Each participant must meet all of the following criteria to be enrolled in the study: 1. Male or female subjects aged greater than or equal to 18 years. 2. Willing and able to provide written informed consent. 3. Presence of dry eye symptoms, confirmed by: OSDI score greater than or equal to 13, and clinically significant symptoms such as dryness, burning, grittiness, foreign‐body sensation,ocular fatigue, fluctuating vision, irritation, or ocular discomfort. 4. At least one objective sign of dry eye disease in the study eye TBUT less than or equal 10 seconds, or corneal fluorescein staining greater than or equal to Grade 1 using Oxford scale, 5. Willingness to use only the assigned study product during the study period. 6. Willingness to comply with study visits, procedures, diary card completion, and investigational product accountability.
Epistemonikos ID: 8f01772aa800f7bb48e380654c3461cb571dbaf1
First added on: Oct 08, 2026