Safety and efficacy of ALG-1007 topical ophthalmic solution – A synthetic peptide that regulates inflammation, in patients with dry eye disease: An exploratory Phase I, open-label, single-center clinical study

2020 ◽  
Vol 3 ◽  
pp. 10
Author(s):  
Richard Lindstrom ◽  
Eric Donnenfeld ◽  
Edward Holland ◽  
Vicken Karageozian ◽  
John Park ◽  
...  
Keyword(s):  
Phase I ◽  
Dry Eye ◽  
Ophthalmic Solution ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Multiple Time ◽  
Open Label ◽  
Safety And Efficacy ◽  
Treatment Groups ◽  
Staining Score

Objectives: The objective of the study was to evaluate the safety and efficacy of ALG-1007 topical ophthalmic solution in patients with dry eye disease (DED). Materials and Methods: This Phase I, prospective, open-label, 12-week study enrolled subjects ≥18 years old with symptoms of DED for at least 6 months and at least one of the following: Total ocular staining score ≥2 or tear film breakup time (TBUT) ≤7 s. Subjects were randomized to four treatment arms: 0.125%, 0.25%, 0.4%, and 0.6% ALG-1007. Subjects received the test drug, 1 drop twice daily, and were followed at multiple time points for 12 weeks. SICCA total ocular staining score, corneal and conjunctival staining score, TBUT, and subject-reported symptoms using the visual analog scale (VAS) symptom index were assessed at baseline and at every visit. The primary safety outcome was percentage and severity of adverse events (AEs). Results: Forty eyes (21 patients) were assigned randomly to four treatment groups (n = 10 per group). Improvement in TBUT, SICCA, and VAS was seen in all groups. The highest dose tested (0.6%) was compared to the lowest dose tested (0.125%) based on change from baseline for all assessments using analysis of variance. Improvement was significantly greater in 0.6% treatment group in terms of TBUT, conjunctiva staining, SICCA, burning, discomfort, photophobia, and the composite symptom score. No serious AEs were reported after 12 weeks of treatment. Conclusion: Outcome measures improved in all the treatment groups. At the highest dose, ALG-1007 demonstrated statistically significant improvement compared to the lowest dose in 7 out of 12 assessments, indicating a dose response. This suggests that the active pharmaceutical ingredient in ALG-1007 is effective in improving signs and symptoms of DED. ALG-1007 was well-tolerated with minimal instillation discomfort and no reported serious AEs.

scholarly journals Lifitegrast Ophthalmic Solution – A Review

2021 ◽  
pp. 186-188
Author(s):  
S. Padmaja ◽  
K. Lakshitha Niyatee Rao
Keyword(s):  
Dry Eye ◽  
Ophthalmic Solution ◽  
Review Article ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Data Bases ◽  
Dry Eyes ◽  
Safety And Efficacy ◽  
Search Terms

Introduction: In this review article the safety and efficacy of of Lifitegrast™ in the management of dry eye disease is described. Methods: Search was carried out using related search terms in data bases like pubmed and related articles were referred. Result: A larger reduction in Eye dryness Score (EDS) was seen with Lifitegrast™. Conclusion: Lifitegrast™ ophthalmic solution 5% provides a new option for the treatment of dry eyes.

scholarly journals Clinical effectiveness of diquafosol ophthalmic solution 3% in Korean patients with dry eye disease: a multicenter prospective observational study

2021 ◽  
Vol 14 (10) ◽  
pp. 1518-1526
Author(s):  
Youngsub Eom ◽  
Keyword(s):  
Dry Eye ◽  
Ophthalmic Solution ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Dependent Manner ◽  
Subjective Symptoms ◽  
Korean Patients ◽  
Staining Score ◽  
Switch Group ◽  
Diquafosol Ophthalmic Solution

AIM: To investigate the effectiveness of diquafosol ophthalmic solution 3% administered in Korean patients with dry eye disease in real-world clinical settings. METHODS: Diquafosol was administered for 8wk to 3 patient groups who received diquafosol as add-on therapy to existing medication (Add group, n=150); received diquafosol only (Monotherapy group, n=196); or discontinued part of their existing medication in favor of diquafosol (Switch group, n=11). Tear break-up time (TBUT), cornea and conjunctival staining based on National Eye Institute/Industry scoring scheme, subjective symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, and meibum quality and expressibility were evaluated at baseline, week 4, and week 8. RESULTS: The mean TBUT increased (from 3.46, 3.92, and 5.84s, respectively, to 5.15, 5.53, and 8.59s, respectively) and corneal staining score decreased (from 2.23, 2.24, and 3.09, respectively, to 0.85, 0.97, and 1.64, respectively) in a time-dependent manner from baseline to week 8 in all three groups. Conjunctival staining score, OSDI questionnaire, and meibum quality and expressibility improved over time from baseline to week 8 in the Add and Monotherapy groups, but differences were not statistically significant in the Switch group. CONCLUSION: Diquafosol improves subjective symptoms and objective signs in patients treated with existing medicines combined with diquafosol and treated solely with diquafosol. Diquafosol can be used as an effective therapeutic agent for dry eye disease or additionally applied in patients who have insufficient response to existing medicines.

scholarly journals Safety and efficacy of amniotic cytokine extract in the treatment of dry eye disease

2019 ◽  
Vol Volume 13 ◽  
pp. 887-894 ◽  
Author(s):  
Elizabeth Yeu ◽  
Damien F Goldberg ◽  
Francis S Mah ◽  
Kenneth A Beckman ◽  
Jodi I Luchs ◽  
...  
Keyword(s):  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Safety And Efficacy

scholarly journals New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study

2020 ◽  
Vol 37 (4) ◽  
pp. 1664-1674 ◽  
Author(s):  
Paolo Fogagnolo ◽  
Eleonora Favuzza ◽  
Daniele Marchina ◽  
Michela Cennamo ◽  
Roberto Vignapiano ◽  
...  
Keyword(s):  
Prospective Study ◽  
Cataract Surgery ◽  
Dry Eye ◽  
Therapeutic Strategy ◽  
Ophthalmic Solution ◽  
Dry Eye Disease ◽  
Eye Disease

scholarly journals One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.

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