Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery

NCT07868965 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 15-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Keywords

Ophtholic Ultra; Sodium hyaluronate; Dry eye; Cataract surgery; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day -1) to Day 90

Secondary Outcomes (7)

• Change in tear film break-up time (TBUT) from baseline to Day 30

  Baseline (Day -1) to Day 30

• Change in Schirmer I test result from baseline

  Baseline (Day -1) to Days 7, 30, and 90

• Corneal fluorescein staining and epithelial defect

  Baseline (Day -1) to Days 7, 30, and 90

• Change in patient-reported ocular symptoms and visual comfort

  Baseline (Day -1) and Days 7, 30, and 90 after surgery

• Change in uncorrected and best-corrected distance visual acuity

  Baseline (Day -1) and Days 7, 30, and 90 after surgery

Study Arms (3)

Arm Label: Ophtholic® Ultra - 3 Months

EXPERIMENTAL

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 Label: Ophtholic® Ultra - 1 Month

EXPERIMENTAL

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 Label: Standard Postoperative Treatment

ACTIVE COMPARATOR

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

Interventions

Ophtholic Ultra DRUG

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.

Arm Label: Ophtholic® Ultra - 3 Months

Standard postoperative therapy without lubricating eye drops OTHER

Standard postoperative therapy after uncomplicated phacoemulsification with intraocular lens implantation, without the use of lubricating ophthalmic drops.

Arm Label: Standard Postoperative Treatment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Kazakh Eye Research Institute: lead

Study Sites (1)

Kazakh Eye Research Institute

Almaty, 050000, Kazakhstan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be masked to treatment allocation. The assessor will not dispense the study product or discuss the assigned treatment regimen with participants and will not be informed of treatment allocation during outcome assessments. Participants will be instructed not to disclose their assigned treatment to the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: A single-center, prospective, randomized, parallel-group, controlled study with three treatment arms. Participants will be randomized in a 1:1:1 ratio to receive standard postoperative treatment plus Ophtholic Ultra for 3 months, standard postoperative treatment plus Ophtholic Ultra for 1 month, or standard postoperative treatment without moisturizing eye drops.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: October 9, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)