Dry Eye Syndromes
Conditions
Keywords
PRO-165, sodium hyaluronate, Chondroitin sulfate 0.18%
Brief summary
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects. Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects. Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant
Detailed description
The study subjects will be recruited from various research centers in western and central Mexico. Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes. The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days. The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico. The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed. To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey). The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.
Interventions
DRUGPRO-165
PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
DRUGArtelac
Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch & Lomb México, S.A. de C.V.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis. The masking will be done by means of identical labels. Which, in accordance with current and applicable regulations, must contain at least: * Name, address and telephone number of the sponsor * Pharmaceutical form and route of administration * Lot Number * Legend Exclusively for clinical studies * Date of Expiry
Intervention model description
controlled, of parallel groups, double blind, randomized, exploratory
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent. * Systemically and ophthalmologically healthy subjects evaluated during the clinical history. * Age between 18 to 45 years. * Both genders. * Blood tests (complete blood count, three element blood chemistry and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%) * Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute) * Visual capacity 20/30 or better, in both eyes. * Intraocular pressure ≥11 and ≤ 21 mmHg.
Exclusion criteria
* Subjects with a history of hypersensitivity to any of the components of the research products. * Subject users of topical ophthalmic medications of any pharmacological group. * Subject users of medication by any other route of administration. * Women who are pregnant or lactating. * Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period. * Subjects with participation in clinical research studies 90 days prior to inclusion in the present study. * Known diagnosis of liver disease * Inability to attend or answer the evaluations made in each of the visits. * Positive tobacco use (specified as cigarette consumption regardless of quantity and frequency) * Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period). * Contact lens users. Medical and therapeutic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Throughout the 13 days of evaluation, including the safety call (day 13). | The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group. |
| Ocular Comfort Index | Baseline Visit (day 0) and Final Visit (day 11) | It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-instillation Symptomatology | Final Visit (day 11) | The subject will be questioned if after applying the medication he felt burning, pruritus, a foreign body sensation and blurred vision. Presence or absence: it will be marked as present (1) or absent (0) for each of the symptoms questioned |
| Visual Acuity (VA) | Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11) | Visual acuity (VA) is a test of visual function. It will be evaluated without refractive correction with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in both fraction (i.e. 20/20) or decimal (i.e. 0.5) formats. In this study, VA is expressed in fraction format. |
| Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11). | The epithelial defects will be evaluated by means of two stains, lysamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the Oxford Scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. The outcome describes the number of pariticipants who presented which grade according to the Oxford Scale. |
| Tear Breakup Time (TBUT) | Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11). | Tear Breakup Time (TBUT) is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds. |
| Intraocular Pressure (IOP) | Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11). | Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRO-165 Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
PRO-165: PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. | 16 |
| 1. Artelac® Nightime Gel Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac
Artelac: Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch & Lomb México, S.A. de C.V. | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | PRO-165 | 1. Artelac® Nightime Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 15 Participants | 31 Participants |
| Age, Continuous | 25.81 years STANDARD_DEVIATION 4.7 | 28.87 years STANDARD_DEVIATION 8.7 | 27.29 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 15 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.67 meters STANDARD_DEVIATION 0.1 | 1.66 meters STANDARD_DEVIATION 0.1 | 1.66 meters STANDARD_DEVIATION 0.1 |
| Region of Enrollment Mexico | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
| Weight | 67.19 kilograms STANDARD_DEVIATION 9 | 69.53 kilograms STANDARD_DEVIATION 12.3 | 68.32 kilograms STANDARD_DEVIATION 10.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 3 / 16 | 5 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
Adverse Events
The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.
Time frame: Throughout the 13 days of evaluation, including the safety call (day 13).
Population: One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population, and therefore considered for the data analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-165 | Adverse Events | 3 Participants |
| 1. Artelac® Nightime Gel | Adverse Events | 5 Participants |
Primary
Ocular Comfort Index
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
Time frame: Baseline Visit (day 0) and Final Visit (day 11)
Population: The PP population was considered for this variable's data analysis. One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-165 | Ocular Comfort Index | Baseline Visit (day 0) | 20.36 Scores in a Scale | Standard Deviation 13.3 |
| PRO-165 | Ocular Comfort Index | Final Visit (day 11) | 15.47 Scores in a Scale | Standard Deviation 11.9 |
| 1. Artelac® Nightime Gel | Ocular Comfort Index | Baseline Visit (day 0) | 15.37 Scores in a Scale | Standard Deviation 14.1 |
| 1. Artelac® Nightime Gel | Ocular Comfort Index | Final Visit (day 11) | 10.99 Scores in a Scale | Standard Deviation 12.8 |
Secondary
Intraocular Pressure (IOP)
Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Population: The PP population was considered for this variable's data analysis. One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-165 | Intraocular Pressure (IOP) | Baseline Visit (day 0) | 14.13 mmHg | Standard Deviation 2.8 |
| PRO-165 | Intraocular Pressure (IOP) | Visit 1 (day 5) | 13.73 mmHg | Standard Deviation 2.5 |
| PRO-165 | Intraocular Pressure (IOP) | Final Visit (day 11) | 13.83 mmHg | Standard Deviation 2.5 |
| 1. Artelac® Nightime Gel | Intraocular Pressure (IOP) | Baseline Visit (day 0) | 14.20 mmHg | Standard Deviation 3.6 |
| 1. Artelac® Nightime Gel | Intraocular Pressure (IOP) | Visit 1 (day 5) | 13.53 mmHg | Standard Deviation 2.8 |
| 1. Artelac® Nightime Gel | Intraocular Pressure (IOP) | Final Visit (day 11) | 14.00 mmHg | Standard Deviation 2.6 |
Secondary
Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)
The epithelial defects will be evaluated by means of two stains, lysamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the Oxford Scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. The outcome describes the number of pariticipants who presented which grade according to the Oxford Scale.
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Population: One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30). The PP population was considered for this variable's data analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Visit 1 (day 5) | Grade 1 | 0 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Final Visit (day 11) | Grade 0 | 15 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green Day 0 (Basal Visit) | Grade 0 | 15 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Visit 1 (day 5) | Grade 0 | 15 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Final Visit (day 11) | Grade 1 | 0 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Visit 1 (day 5) | Grade 0 | 15 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Baseline Visit (day 0) | Grade 0 | 15 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Final Visit (day 11) | Grade 0 | 15 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Baseline Visit (day 0) | Grade 1 | 0 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Visit 1 (day 5) | Grade 1 | 0 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Final Visit (day 11) | Grade 1 | 0 Participants |
| PRO-165 | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green Day 0 (Basal Visit) | Grade 1 | 0 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Final Visit (day 11) | Grade 1 | 1 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green Day 0 (Basal Visit) | Grade 1 | 0 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Visit 1 (day 5) | Grade 0 | 15 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Visit 1 (day 5) | Grade 1 | 0 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Final Visit (day 11) | Grade 0 | 15 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Baseline Visit (day 0) | Grade 1 | 1 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Visit 1 (day 5) | Grade 0 | 15 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Visit 1 (day 5) | Grade 1 | 0 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green Day 0 (Basal Visit) | Grade 0 | 15 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Lysamine Green; Final Visit (day 11) | Grade 1 | 0 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Baseline Visit (day 0) | Grade 0 | 14 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) | Fluorescein; Final Visit (day 11) | Grade 0 | 14 Participants |
Secondary
Number of Participants With Post-instillation Symptomatology
The subject will be questioned if after applying the medication he felt burning, pruritus, a foreign body sensation and blurred vision. Presence or absence: it will be marked as present (1) or absent (0) for each of the symptoms questioned
Time frame: Final Visit (day 11)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRO-165 | Number of Participants With Post-instillation Symptomatology | Burning sensation | 4 Participants |
| PRO-165 | Number of Participants With Post-instillation Symptomatology | Pruitus | 7 Participants |
| PRO-165 | Number of Participants With Post-instillation Symptomatology | Foreign Body Sensation | 9 Participants |
| PRO-165 | Number of Participants With Post-instillation Symptomatology | Blurry Vision | 15 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Post-instillation Symptomatology | Pruitus | 6 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Post-instillation Symptomatology | Blurry Vision | 15 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Post-instillation Symptomatology | Burning sensation | 8 Participants |
| 1. Artelac® Nightime Gel | Number of Participants With Post-instillation Symptomatology | Foreign Body Sensation | 8 Participants |
Secondary
Tear Breakup Time (TBUT)
Tear Breakup Time (TBUT) is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).
Population: One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30). The PP population was considered for this variable's data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-165 | Tear Breakup Time (TBUT) | Baseline Visit (day 0) | 12.67 Seconds | Standard Deviation 2.9 |
| PRO-165 | Tear Breakup Time (TBUT) | Visit 1 (day 5) | 13.53 Seconds | Standard Deviation 3.4 |
| PRO-165 | Tear Breakup Time (TBUT) | Final Visit (day 11) | 13.47 Seconds | Standard Deviation 3.9 |
| 1. Artelac® Nightime Gel | Tear Breakup Time (TBUT) | Baseline Visit (day 0) | 12.80 Seconds | Standard Deviation 3 |
| 1. Artelac® Nightime Gel | Tear Breakup Time (TBUT) | Visit 1 (day 5) | 13.47 Seconds | Standard Deviation 3.1 |
| 1. Artelac® Nightime Gel | Tear Breakup Time (TBUT) | Final Visit (day 11) | 13.40 Seconds | Standard Deviation 2.8 |
Secondary
Visual Acuity (VA)
Visual acuity (VA) is a test of visual function. It will be evaluated without refractive correction with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in both fraction (i.e. 20/20) or decimal (i.e. 0.5) formats. In this study, VA is expressed in fraction format.
Time frame: Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11)
Population: The PP population was considered for this variable's data analysis. One patient in the PRO-165 group was lost during the course of the study, but did attend to Visit 1, so this subject was included in the ITT population (31) but not in the PP (30).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-165 | Visual Acuity (VA) | Baseline Visit (day 0) | 19.33 Decimal Score (Snellen Chart) | Standard Deviation 3.7 |
| PRO-165 | Visual Acuity (VA) | Visit 1 (day 5) | 19.33 Decimal Score (Snellen Chart) | Standard Deviation 3.7 |
| PRO-165 | Visual Acuity (VA) | Final Visit (day 11) | 20.00 Decimal Score (Snellen Chart) | Standard Deviation 4.6 |
| 1. Artelac® Nightime Gel | Visual Acuity (VA) | Baseline Visit (day 0) | 18.00 Decimal Score (Snellen Chart) | Standard Deviation 2.5 |
| 1. Artelac® Nightime Gel | Visual Acuity (VA) | Visit 1 (day 5) | 19.33 Decimal Score (Snellen Chart) | Standard Deviation 3.7 |
| 1. Artelac® Nightime Gel | Visual Acuity (VA) | Final Visit (day 11) | 18.67 Decimal Score (Snellen Chart) | Standard Deviation 4 |