A case study in managing 40 sites, nearly 600 randomized subjects and complex clinical endpoints across multiple geographies

Complex ophthalmology trials require precise site execution, strong patient engagement, robust data management, rigorous statistical analysis and continuous regulatory readiness.

Navitas Life Sciences, a global CRO, conducted a clinical endpoint equivalence trial across 40 clinical sites in India and Russia, demonstrating what it takes to manage this complexity.

The randomized investigator masked multi-center parallel-group study evaluated equivalence in patients with primary open-angle glaucoma or ocular hypertension. The study included 598 randomized subjects and required close coordination across clinical operations, data management, biostatistics, statistical programming, sites and regulatory stakeholders.

The study achieved its predefined equivalence objectives. Subject compliance exceeded 96% and three participating clinical sites subsequently underwent USFDA inspections with no Form 483 observations.

For sponsors conducting ophthalmology clinical trials this case demonstrates how therapeutic expertise operational precision proactive monitoring data integrity advanced analytics and statistical rigor can support complex clinical research.

The study

A leading global pharma required support for a complex clinical endpoint equivalence trial in ophthalmology, evaluating IOP reduction in patients with primary open-angle glaucoma or ocular hypertension.

The objective was to establish equivalence in clinical outcomes between two ophthalmic interventions in patients with primary open-angle glaucoma or ocular hypertension.

The 13 week study consisted of:

• 6 week screening period
• 6 week treatment period
• 1 week follow-up period
• 598 randomized subjects
• 40 actively recruiting clinical sites across India and Russia
• Two treatment arms
• Ophthalmic interventions administered three times daily in both eyes
• Randomization through IWRS

Participants were adults with IOP between 22 and 34 mmHg and adequate visual acuity with a minimum requirement of 0.8 logMAR.

The primary objective was to evaluate therapeutic equivalence based on intraocular pressure reduction.

Executing across 40 sites

Navitas Life Sciences implemented a structured execution strategy focused on site readiness protocol compliance and continuous oversight.

Investigators and site staff received targeted training covering protocol requirements Good Clinical Practice and ALCOA principles. Standard Operating Procedures were harmonized across sites to promote consistent execution.

Frequent on-site and remote monitoring visits were combined with centralized data review and proactive risk based monitoring.

Protocol deviations involving dosing windows and assessment sequencing were identified early and addressed through corrective actions and retraining.

Subject compliance exceeded 96%.

The study also involved stringent dosing requirements including an 08:00 AM ± 30 minute dosing window. Maintaining this schedule required active patient engagement and close site oversight.

Protecting data quality

The study relied on both paper based source documents and electronic data capture systems. This required meticulous reconciliation and contemporaneous data entry.

Navitas implemented continuous data cleaning query resolution and source to system reconciliation.

The clinical data management team worked closely with site monitors to resolve issues promptly and support timely database lock.

Navitas also leveraged OneClinical® an AI driven analytics platform providing near real-time visibility into study performance site compliance and data quality.

This supported decision making and adaptive monitoring strategies throughout the study.

Learn more about Oneclinical Analytics here.

Managing the statistical complexity

The study evaluated ITT PP and Safety populations.

Primary endpoints were mean IOP differences at Day 14 and Day 42 with predefined equivalence margins of:

• ±1.5 mmHg at Day 14
• ±1.0 mmHg at Day 42

Secondary endpoints included change from baseline IOP.

All endpoints met the predefined equivalence criteria.

The statistical analysis incorporated Mixed Model Repeated Measures or MMRM for longitudinal data with appropriate covariance structures and baseline covariate adjustments.

Sensitivity analyses using ITT and PP populations addressed protocol deviations and missing data.

Navitas biostatistics and statistical programming teams also performed extensive programming and validation of SAS outputs with cross functional review between biostatistics and clinical teams.

What sponsors should look for in an ophthalmology CRO

For organizations planning ophthalmology clinical research the case highlights several important considerations when selecting a clinical research partner.

Sponsors should look for:

• Relevant ophthalmology therapeutic expertise
• Experience with complex ophthalmic endpoints
• Multi-country clinical operations capabilities
• Strong patient recruitment and retention strategies
• Rigorous protocol and dosing compliance
• Risk based monitoring capabilities
• Robust data management processes
• Experienced biostatistics and statistical programming teams
• Technology enabled study oversight
• Strong regulatory and inspection readiness
• Integrated clinical operations data management and statistical capabilities.

This is particularly relevant when considering What should I consider when choosing an ophthalmology CRO for clinical trials?

The answer should extend beyond geographic coverage or a list of services. Sponsors need a partner capable of managing the scientific operational statistical and regulatory complexity of the study as an integrated program.

What services should an ophthalmology CRO provide?

When considering What are the key services offered by ophthalmology contract research organizations? sponsors should look for integrated capabilities spanning clinical study planning site feasibility site selection patient recruitment site initiation investigator training clinical monitoring risk based monitoring data management biostatistics statistical programming safety support and regulatory support.

A full-service ophthalmology CRO should be capable of connecting these functions throughout the clinical development lifecycle. An experienced ophthalmology contract research organization should also bring therapeutic knowledge that allows teams to anticipate the practical challenges associated with ophthalmic endpoints patient eligibility assessment sequencing dosing requirements and site workflows.

Support for Stellar Ophthalmology Studies

This case demonstrates that successful clinical endpoint equivalence studies require disciplined execution across every participating site, continuous attention to data quality, proactive risk management experienced statistical teams and regulatory readiness throughout the study lifecycle.

For sponsors conducting ophthalmology research, the right CRO should function as an integrated extension of the development team. Navitas Life Sciences combines therapeutic expertise clinical operations, data management, biostatistics, statistical programming and technology enabled oversight to support complex global clinical research programs.

The experience from this 40 site study demonstrates how operational precision and scientific rigor can deliver robust clinical evidence while maintaining a strong state of regulatory readiness. Partner with us for all your ophthalmology studies.

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