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
Overview
- Phase
- Phase 2
- Intervention
- Sodium Hyaluronate Ophthalmic 0.4% Six times per day
- Conditions
- Dry Eye
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Change in Ocular Surface Disease Index (OSDI)
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years old.
- •Being capable of voluntarily grant a signed informed consent.
- •Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
- •Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.
- •Presenting a mild to moderate dry eye disease diagnosis, defined as:
- •OSDI score between 13 and 32, plus one of the following:
- •More than 5 dots of corneal staining
- •More than 9 dots of conjunctival staining
- •Tear Break-up Time (BUT) \< 10 seconds
Exclusion Criteria
- •Pregnancy, breastfeeding or planning to become pregnant during the time of the study
- •Having participated in clinical trials within 30 days prior to signing this study's informed consent form.
- •Having participated previously in this study.
- •Best Corrected Visual Acuity (BCVA) equal or worse than 20/200, in either eye.
- •Diagnosis of any of the following:
- •Allergic, viral or bacterial conjunctivitis
- •Anterior blepharitis
- •Parasite infestation of ocular structures (Demodex, for example)
- •Unresolved history of ocular trauma
- •Scarring diseases of the ocular surface
Arms & Interventions
Group 3
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Intervention: Sodium Hyaluronate Ophthalmic 0.4% Six times per day
Group 1
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop twice a day (BID) in both eyes (OU) during 30 days.
Intervention: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)
Group 2
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop four times a day (QID) in both eyes (OU) during 30 days.
Intervention: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)
Outcomes
Primary Outcomes
Change in Ocular Surface Disease Index (OSDI)
Time Frame: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).
OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.
Incidence of Adverse Events (AE)
Time Frame: Up to Day 33 (+ 1) (safety call).
Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution and whether it was considered related or not to the investigation products.
Secondary Outcomes
- Change in Tear Break-up Time (BUT)(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Conjunctival and Corneal Staining With Lissamine Green(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Conjunctival and Corneal Staining With Fluorescein(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Conjunctival Hyperemia(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Incidence of Chemosis(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Best Corrected Visual Acuity (BCVA)(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Intraocular Pressure (IOP)(BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).)