A Phase 4 interventional study of Ophtholic Ultra and Ophtholic Ultra in Dry Eye Disease (DED), sponsored by Kazakh Eye Research Institute. Active, not recruiting at 1 site in Kazakhstan. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Kazakh Eye Research Institute · Phase 4, Interventional, and Treatment
Study of the Effectiveness and Safety of Ophtholic Ultra in Preventing and Correcting Ocular Surface Disturbances After Uncomplicated Cataract Surgery
This is a single-center, prospective, randomized, controlled, assessor-masked clinical study evaluating the effectiveness and safety of Ophtholic Ultra, a preservative-free moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate, in patients undergoing uncomplicated cataract surgery.
Cataract surgery can temporarily affect the ocular surface and tear film, leading to dry eye symptoms, discomfort, epithelial changes, and reduced tear film stability. This study will evaluate whether adding Ophtholic Ultra to standard postoperative treatment can improve ocular surface condition after cataract surgery.
Approximately 60 adults aged 50 to 70 years with age-related cataract will be randomized into three groups. One group will receive standard postoperative treatment plus Ophtholic Ultra for 3 months, the second group will receive standard postoperative treatment plus Ophtholic Ultra for 1 month, and the third group will receive standard postoperative treatment without moisturizing eye drops.
The primary outcome will be the change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery. Secondary outcomes will include Schirmer I test results, corneal epithelial staining and defects, visual acuity, patient-reported ocular symptoms and comfort, refractive outcomes, adherence, tolerability, and adverse events.
Participants will be assessed before surgery and on Days 7, 30, and 90 after surgery.
This is a single-center, prospective, randomized, parallel-group, controlled, assessor-masked clinical study designed to evaluate the effectiveness and safety of Ophtholic Ultra in the prevention and correction of ocular surface disturbances following uncomplicated phacoemulsification cataract surgery with intraocular lens implantation.
The study will be conducted at the Kazakh Eye Research Institute in Almaty, Republic of Kazakhstan. The study population will consist of adults aged 50 to 70 years with age-related cataract for whom elective cataract surgery is planned.
A total of 60 participants will be randomized in a 1:1:1 ratio into three parallel treatment groups. Each participant will contribute one study eye.
Participants in Group 1 will receive standard postoperative treatment plus Ophtholic Ultra for 3 months. Participants in Group 2 will receive standard postoperative treatment plus Ophtholic Ultra for 1 month. Participants in Group 3 will receive standard postoperative treatment without additional moisturizing eye drops.
Ophtholic Ultra is a preservative-free, multidose moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate. In the treatment groups, the study product will be administered as one drop into the operated eye four times daily, beginning on Day -1 before surgery and continuing according to the assigned treatment duration.
The primary objective is to determine whether the addition of Ophtholic® Ultra to standard postoperative treatment improves tear film stability after uncomplicated cataract surgery. The primary outcome measure is the between-group difference in the change in mean tear film break-up time (TBUT), measured from baseline to Day 90 after surgery.
Secondary outcomes include changes in Schirmer I test results, corneal fluorescein staining and epithelial defects, patient-reported ocular symptoms and visual comfort, uncorrected and best-corrected distance visual acuity, refractive outcomes, adherence to treatment, tolerability, and the incidence and characteristics of adverse events.
Participants will undergo a baseline assessment on Day -1 before surgery and postoperative assessments on approximately Day 7, Day 30, and Day 90. Ophthalmic assessments will include slit-lamp examination, visual acuity, refraction, TBUT, fluorescein staining, evaluation and documentation of the corneal epithelium, and Schirmer I testing.
Randomization will be performed using block randomization with a 1:1:1 allocation ratio and variable block sizes. Outcome assessors will be masked to treatment allocation. Participants will be instructed not to disclose their assigned treatment to the assessor and not to bring the study product container to assessment visits.
The study will evaluate the safety and tolerability of the study product throughout the follow-up period. Adverse events will be documented and assessed during study visits.
The expected duration of the overall project is approximately 6 months, including participant recruitment, up to 3 months of follow-up for the last randomized participant, database closure, data analysis, and preparation of the final study report.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Kazakh Eye Research Institute is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
1. Age 50 to 70 years, inclusive. 2. Age-related cataract with a clinical indication for planned phacoemulsification with intraocular lens implantation. 3. Ability to understand the study information and provide written informed consent. 4. Willingness and ability to comply with the scheduled study visits and study procedures. 5. Ocular surface symptoms, including burning, dryness, tearing, frequent blinking, or foreign body sensation. 6. Corneal transparency sufficient to perform tear film break-up time assessment and fluorescein staining. 7. Uncomplicated cataract surgery completed without complications requiring a change in standard postoperative management.
Exclusion Criteria
1. Active infectious or clinically significant inflammatory disease of the ocular surface, eyelids, or lacrimal system. 2. Severe dry eye disease requiring continuous anti-inflammatory, immunomodulatory, or intensive tear replacement therapy. 3. Sjögren syndrome, active systemic autoimmune disease, or another condition expected to substantially affect tear production. 4. Corneal scar, dystrophy, degeneration, marked irregularity, or neurotrophic keratopathy. 5. Significant meibomian gland dysfunction requiring immediate specialized treatment. 6. Uveitis, uncontrolled glaucoma, or previous corneal refractive or other corneal surgery within 12 months before enrollment. 7. Contact lens use within 14 days before the baseline assessment. 8. Use of artificial tears or other topical ophthalmic products affecting the ocular surface that cannot be discontinued for at least 24 hours before baseline testing. 9. Known allergy or hypersensitivity to any component of Ophtholic® Ultra or fluorescein. 10. Any serious medical or cognitive condition that, in the investigator's opinion, makes participation unsafe or prevents reliable study data collection.
Exclusion Criteria Before Randomization
1. Intraoperative posterior capsule rupture, significant vitreous loss, inability to implant the planned intraocular lens, or another significant intraoperative complication. 2. Need for additional surgical intervention or a change in the standard postoperative eye drop regimen that substantially differs from the study protocol. 3. Withdrawal of informed consent before randomization.
Participants will receive standard postoperative treatment after uncomplicated cataract surgery plus Ophtholic® Ultra, one drop in the operated eye four times daily, from Day -1 before surgery through Day 30 after surgery.
Drug: Ophtholic Ultra
Arm Description: Participants will receive standard postoperative treatment after uncomplicated cataract surgery plus Ophtholic® Ultra, one drop in the operated eye four times daily, from Day -1 before surgery through Day 30 after surgery.
Drug: Ophtholic Ultra
Arm Description: Participants will receive standard postoperative treatment after uncomplicated cataract surgery without additional moisturizing eye drops.
Other: Standard postoperative therapy without lubricating eye drops
Preservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 90, in addition to standard postoperative therapy.
Preservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 30, in addition to standard postoperative therapy.
Standard postoperative therapy after uncomplicated phacoemulsification with intraocular lens implantation, without the use of lubricating ophthalmic drops.
Change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery
The primary outcome is the between-group difference in the change in mean tear film break-up time (TBUT), measured in seconds, from baseline (Day -1 before surgery) to Day 90 after uncomplicated cataract surgery.
Time frame: Baseline (Day -1) to Day 90
Change in tear film break-up time (TBUT) from baseline to Day 30
Change in mean tear film break-up time (TBUT), measured in seconds, from baseline (Day -1 before surgery) to Day 30 after cataract surgery, with comparison between treatment groups.
Time frame: Baseline (Day -1) to Day 30
Change in Schirmer I test result from baseline
Change in tear production measured by the Schirmer I test, in millimeters, from baseline (Day -1 before surgery) to postoperative Days 7, 30, and 90.
Time frame: Baseline (Day -1) to Days 7, 30, and 90
Corneal fluorescein staining and epithelial defect
Change in corneal epithelial condition assessed by fluorescein staining and documentation of epithelial defects after cataract surgery.
Time frame: Baseline (Day -1) to Days 7, 30, and 90
Change in patient-reported ocular symptoms and visual comfort
Change in patient-reported ocular surface symptoms, including dryness, burning, foreign body sensation, tearing, frequent blinking, and visual discomfort, following cataract surgery.
Time frame: Baseline (Day -1) and Days 7, 30, and 90 after surgery
Change in uncorrected and best-corrected distance visual acuity
Change in uncorrected distance visual acuity and best-corrected distance visual acuity, measured in LogMAR, following cataract surgery.
Time frame: Baseline (Day -1) and Days 7, 30, and 90 after surgery
Accuracy of intraocular lens power calculation
Assessment of the effect of Ophtholic® Ultra on the accuracy of intraocular lens power calculation and postoperative refractive outcomes following cataract surgery.
Time frame: Baseline (Day -1) and Day 90 after surgery
Incidence of adverse events, treatment tolerability, and adherence
Incidence and characteristics of adverse events, tolerability of Ophtholic® Ultra, and adherence to the assigned treatment regimen during the study period.
Time frame: From Day -1 through Day 90 after surgery
Plan to share: No — We do not plan to share individual participant data with other researchers.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Kazakh Eye Research Institute