CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 141 enrolled
Drug / intervention
Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID) +2 moredrug
Likely dose
Sodium hyaluronate ophthalmic 0.4% one drop at three dosing frequencies: twice daily, four times daily, or six times dailyAI-extracted
Key inclusion· 4
  • ✓Age 18 years or older
  • ✓Mild to moderate dry eye disease defined by OSDI score 13-32 plus at least one of: corneal staining >5 dots, conjunctival staining >9 dots, or tear break-up time <10 seconds
  • ✓Willing and able to attend scheduled visits and comply with study procedures
  • ✓Capable of providing informed consent
Key exclusion· 10
  • ✕Pregnancy, breastfeeding, or planning pregnancy during study
  • ✕Best corrected visual acuity worse than 20/200 in either eye
  • ✕Ocular surface diseases including allergic, viral, or bacterial conjunctivitis; anterior blepharitis; corneal/conjunctival ulcers; filamentary keratitis; neurotrophic keratitis; bullous keratopathy; neoplastic diseases of ocular surface; scarring diseases; or fibrovascular proliferations
  • ✕Retinal or posterior segment disease requiring treatment or threatening visual outcome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04704531
NCT04704531Phase 2Completed
CompareCT.gov

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution Applied in Three Different Dosage Schemes as Treatment for Mild to Moderate Dry Eye

Laboratorios Sophia S.A de C.V.·interventional·Posted Jan 11, 2021·Updated Mar 3, 2026

In Brief

A Phase 2 clinical trial evaluating Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID), Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID), and 1 other intervention for Dry Eye. Completed, enrolled 141 participants across 1 site.

Detailed Summary

Phase II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 11, 2021
Enrollment StartJan 3, 2022
Primary CompletionJun 8, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.5 years ago

Interventions

Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)drug

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.

Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)drug

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.

Sodium Hyaluronate Ophthalmic 0.4% Six times per daydrug

Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.